GMDN

Frequently asked questions (FAQs)

FAQs

  • What is the GMDN?
    The Global Medical Device Nomenclature (GMDN) is a system of internationally agreed descriptors and is the leading global standard for the naming, classification and categorisation of medical device products. The GMDN Database lists all the Terms, which are currently available to name and describe medical devices, although new Terms are regularly issued to cope with new medical device innovations. The GMDN is owned and managed by the GMDN Agency, a non-profit organisation. Anyone can register for free as a member on the GMDN website to access and use any GMDN Term. The GMDN provides Healthcare Professionals, Regulators, Manufacturers and others with a common language to communicate and share information. To find out more about the GMDN and its history, visit our About Us section.  
  • What is the GMDN Agency?
    The GMDN Agency is a registered UK charity and non-profit organisation responsible for the ongoing maintenance of the GMDN Database. The GMDN Agency is a wholly UK based organisation with no subsidiaries, franchises or licenced entities outside of the UK. The Agency was established to provide Health Authorities and Regulators, Healthcare Providers, Manufacturers and others with a system that allows an exchange of medical device information and supports patient safety.
    Our vision is: To provide a single common language for all medical technology, and for it to be adopted by medical device Regulators, Manufacturers and other participants in healthcare systems worldwide.
    Our mission is: To be the global leader in naming, describing and unambiguously identifying medical devices for the protection of patients.
    Read more about our vision and objective in our 5 year strategy.
    You can download our latest annual report from the Charities Commission website.
  • Who can access and use the GMDN?
    Anyone can register for free as a member on the GMDN website to access and use any GMDN Term. Registered members can check their GMDN Term status at any time without charge. The full GMDN is available for free to Regulators, Healthcare Providers and Academic Researchers. Device Manufacturers can choose to register for a paid notification service that can save them time in managing the GMDN Terms they use. Certain qualified members, such as Governments, Hospitals, and Academics, can register to obtain full sets of GMDN Terms updated regularly without charge. Access to GMDN is open to anyone in any country and allows members to access all Term Names, Definitions, and Codes, view proposed new changes to Terms, provide comments, and ask questions. All members must register to preserve the GMDN Database's integrity and security, allowing direct communication and meeting regulatory requirements. Registration supports data integrity, timely updates, and global contributions. This is the same requirement to register on the WHO website to see the WHO-FIC (ICD-11 draft items).
  • Do we need to have a GMDN account in every country we operate?
    If you are part of an international group of companies, we recommend you only have one GMDN account and therefore can be globally consistent in your selection of GMDN Terms for your entire product range. Please contact us for assistance and to work out the best membership and account use option for your organisation.
  • How is the GMDN funded?
    The GMDN Agency is a UK charity and a non-profit organisation and is responsible for creating and maintaining the GMDN Database. GMDN Term Names and Definitions are freely available to all members, allowing them to find the most appropriate GMDN Term and related GMDN Code. The full GMDN is available for free to Regulators, Healthcare Providers and Academic Researchers.

    Medical device Manufacturers can choose to register for a paid membership to better manage their company's GMDN Terms, which is the primary source of income for the Agency. Paid membership is an option only for medical device Manufacturers, Consultancy Organisations, and other Commercial Organisations. The GMDN has approximately 15,000 members, with 91% on basic (free) membership. The membership structure ensures that no member contributes more than 2% of the GMDN Agency’s income, ensuring the Agency's independence.
  • How many countries use the GMDN?
    The GMDN has members across 145 countries, making it the most widely used global nomenclature, helping Regulators,  Manufacturers, Healthcare Providers and Authorities and Researchers to communicate with one another accurately. Governments using GMDN (74 as of April 2023):
    • Argentina
    • Armenia
    • Australia
    • Austria
    • Bahrain
    • Belarus
    • Belgium
    • Bhutan
    • Bosnia and Herzegovina
    • Brazil
    • Bulgaria
    • Canada
    • Chile
    • Colombia
    • Costa Rica
    • Croatia
    • Cuba
    • Czechia
    • Denmark
    • Ecuador
    • Estonia
    • Ethiopia
    • France
    • Ghana
    • Indonesia
    • Ireland
    • Italy
    • Japan
    • Kazakhstan
    • Kenya
    • Kyrgyzstan
    • Latvia
    • Lebanon
    • Malaysia
    • Mexico
    • Montenegro
    • Nepal
    • Netherlands
    • New Zealand
    • Nicaragua
    • North Macedonia
    • Norway
    • Oman
    • Pakistan
    • Panama
    • Peru
    • Poland
    • Portugal
    • Qatar
    • Republic of Moldova
    • Russian Federation
    • Rwanda
    • Saudi Arabia
    • Senegal
    • Sierra Leone
    • Singapore
    • Slovenia
    • South Africa
    • Spain
    • Sudan
    • Sweden
    • Switzerland
    • Taiwan
    • Tajikistan
    • Thailand
    • Tunisia
    • Türkiye
    • Uganda
    • Ukraine
    • United Kingdom of Great Britain and Northern Ireland
    • United Republic of Tanzania
    • United States of America
    • Venezuela
    • Vietnam
  • How are membership prices for Manufacturers and Commercial Organisations decided?
    The GMDN Agency is a UK charity and a non-profit organisation and is responsible for creating and maintaining the GMDN Database. Our paid membership levels are based on a company or organisations annual gross revenue.

    This ensures our membership fees fairer and more equitable for paying organisations. You can see the prices for membership for Manufacturers or Commercial Organisations at this link.

    Our membership structure ensures that no member contributes more than 2% of the GMDN Agency’s income, ensuring the Agency's independence.
  • Why is the GMDN copyrighted?
    The GMDN Agency owns the copyright to the GMDN as this helps us protect and maintain the integrity of the data ensuring that any publicly available data is accurate, up to date and supports patient safety.

    We have several licensing agreements with many Governmental Regulators, including the United States of America's FDA, the UK’s MHRA and Australia’s TGA, to publish the GMDN to support patient safety.

    If you want to know more about how we can work together, please contact us
  • How can I get a GMDN Code for my product?
    All registered GMDN members can access the GMDN Database which currently has almost 25,000 GMDN Term Names which group your medical devices.
    Anyone can register for free as a member on the GMDN website to access and use any GMDN Term Names, Definitions and GMDN Codes as well as view proposed new changes to Terms, provide comments, and ask questions.
    All members must register to preserve the GMDN Database's integrity and security, allowing direct communication and meeting regulatory requirements.
    Registration supports data integrity, timely updates, and global contributions.  After joining the GMDN, Terms and Codes can be found on our website using a simple search tool.
  • Do I register my product with the GMDN Agency?
    No, the GMDN Agency is not a Medical Device Regulator. We make available the generic GMDN Terms to standardize the naming and grouping of medical devices. This improves communication within the health-sector and helps Regulators better understand information about medical device use.
  • What is an Enquiry?
    An Enquiry is a process used by Members to submit details of a medical device for which a GMDN Term has not been found on the GMDN Database. It allows Members to communicate with our Term Development Team, who will ensure the creation or assignment of an appropriate GMDN Term. An Enquiry should be submitted through our Enquiry Service and be restricted to either a single product or multiple related products (examples of related products are devices that are connected and/or used in combination with each other as parts of the same system/kit/set or have the same or very similar intended uses). Separate Enquiries must be submitted for products unrelated to each other).
  • What is an Enquiry Service Credit?
    “Enquiry Service Credits” are for Basic members and paid Manufacturer and Consultancy or Commercial Organisation members. Enquiry Service Credits are included with your GMDN membership, which can be used through the GMDN Enquiry Service for a single product/Term assignment Enquiry. Paid Manufacturer Members receive unlimited free priority Enquiries. Basic and Consultancy or Commercial Organisation members receive 2 Free Enquiry Service Credits, any subsequent Enquiries are charged at £100 per submission.

    If you run out of Enquiry Service Credits, please contact us to discuss your options.
  • Do all Manufacturers need to find GMDN Codes for their products?
    Medical Device Regulators specify the use of the GMDN to meet their national requirement. For example, in the USA the FDA require the GMDN as part of their UDI Rule. The medical device Regulators in over 90 countries are using the GMDN to support patient safety and often require the GMDN Code attribute in their medical device listing or approval process.
  • What is the difference between a GMDN Term and a GMDN Code?
    The GMDN Term is made up of several data elements, including the Term Name, GMDN Code and a Definition. As seen in this example:

    - Term Name: 'General-purpose syringe'
    - GMDN Code: '47017'
    - Definition: 'A sterile device consisting of a calibrated barrel (cylinder) with plunger...'.

    Using the GMDN Database members can search all the Term Names and Definitions for the appropriate description of their product. Once selected, the GMDN Code is made available to the member and then used for regulatory or data exchange purposes. Selected Codes are automatically added to the members 'My Terms' list for future reference and tracking for status changes by us.
  • How often are new GMDN Terms issued?
    New Terms are issued regularly following requests from members who are developing new technology or due to feedback from medical device Regulators. The GMDN Database is updated daily. Certain account types are informed by email if a Term in their 'My Terms' list is modified or made obsolete.
  • What if my GMDN Term is modified by the GMDN Agency?
    A GMDN Term Name or Definition may need to be modified to expand its scope or the Term may be made obsolete if it no longer accurately represents a product group. Certain account types with these particular Terms in their 'My Terms' list will be notified automatically by email, so that they can consider whether or not to choose an alternative Term for their product. All members can check the status of a GMDN Term by entering the GMDN Code in our search engine.
  • How does the GMDN Database evolve?
    The GMDN Database is a dynamic database that reflects the dynamic nature of the medical devices sector. New Terms are added regularly to keep the nomenclature up to date with current medical technology. The database is updated daily, and members are notified via email if a Term in their "My Terms" list is modified or made obsolete. New Terms are added to prevent overlap or duplication of Terms and are necessary to fit new products into the nomenclature. Terms are also expanded to cover slight variations of products, and wording changes are made to ensure consistency.
     
    Yearly average changes in the GMDN Database for financial year 2023/24 was a follows (01/04/23 - 31/03/24):
    • New Terms: 0.91%
    • Term Obsoleted: 0.44%
    • Terms Amended: 1.78%
    • Total GMDN Terms 24,975
    • Yearly average change rates have been consistent in the last four years (2021-2022-2023-2024)
    • 763 enquires raised by GMDN Users (01/04/23-31/03/24)
  • Can a GMDN Term defining a system be assigned to all of the system components?
    No. Every device (placed on the market separately) should be assigned a single GMDN Term that accurately represents that device. Only products that exist as a system at the point-of-sale should be assigned to a Term defining a system. System components should be assigned their own Term (this also applies to implantables and accessories/components of a parent device).
  • Why are GMDN Terms obsoleted?
    Obsoleting Terms is necessary to maintain the quality of the nomenclature in the dynamic world of medical devices. These changes may cause short-term disruption, but replacement Terms are easily found on the GMDN website. The examples below highlight the most common reasons for obsoletion:

    1. Systems that don’t exist at the point of sale
    EXAMPLE: The GMDN Term Video capsule endoscopy system was made obsolete as it was found that these systems do not exist under a single UDI (SKU) at the point of sale (the system is compiled at the point of use). A GMDN Term represent device at the point of sale. For this obsolete Term we therefore provide these Alternative Terms:
    Video capsule endoscopy system capsule magnetic manipulation unit
    Video capsule endoscopy system capsule magnetic activator
    Video capsule endoscopy system capsule
    Video capsule endoscopy system application software
     
    2. Excess granularity
    EXAMPLE: These stent terms were made obsolete to be replaced by a single Term of broader scope that better represents the intended use of devices on the market, removing overly cumbersome granularity:
    Bare-metal renal artery stent (obsolete)
    Iliac artery stent, bare-metal (obsolete)
    Biliary/peripheral artery stent (obsolete)
    Alternative Term:
    Peripheral artery stent, bare-metal

    3. Unclear definition – Sometimes a GMDN Term definition is not clear or overlaps with other concepts. A lot of effort is put into this being avoided and instances are not common.
    EXAMPLE: The GMDN Term Orthopaedic bone wire was made obsolete as the scope of the Term had become too broad and overlapped with related Terms. These related Terms are provided in the Alternative Terms list.

    4. Innovation – As technologies evolve the attributes which distinguish devices within a particular area may need to be re-considered. The scope of a GMDN Term cannot be narrowed so if more specific attributes are to be introduced we must make Term(s) obsolete and create new, more granular Terms.
    EXAMPLE: Following extensive consultation with industry the GMDN Term Multi-axis foot prosthesis was made obsolete and these Alternative Terms created:
    Motorized external ankle-foot prosthesis
    Mechatronic external ankle-foot prosthesis
    Mechanical-resistance external ankle-foot prosthesis
    Hydraulic/pneumatic external ankle-foot prosthesis

    5. Regulatory Feedback – The GMDN has strong relationships with regulators and as a dynamic UDI database data field sometimes there is a need for the GMDN to specify new attribute distinctions to meet the needs of the regulators.
    EXAMPLE: Following the discovery of a clinical significance of textured surface breast implants with respect to BIA-ALCL lymphoma, the GMDN was asked to specify the “textured” attribute within its Terms. These terms were made obsolete:
    Saline-filled breast implant, unstructured (obsolete)
    Silicone gel-filled breast implant (obsolete)
    These Alternative Terms were published:
    Autologous adipose tissue reconstruction breast implant
    Saline-filled breast implant, internally-structured
    Saline-filled breast implant, unstructured, smooth-surface
    Saline-filled breast implant, unstructured, textured-surface
    Silicone gel/saline-filled breast implant
    Silicone gel-filled breast implant, polyurethane-foam-surface
    Silicone gel-filled breast implant, smooth-surface
    Silicone gel-filled breast implant, textured-surface
  • How do I find Alternative Terms for Obsoleted Terms?
    GMDN Agency guidance on how to identify Alternative Terms for Obsolete Terms in the GMDN Database: Manufacturer Members:
    • Go to your My Terms here https://members.gmdnagency.org/Terms/MyTerms section and select ‘Obsolete’ in the Status field
    • By clicking on Details, you will be taken to the Obsolete Term details page where you will find the list of suggested Alternative Term(s) at the bottom of the page
    • Please add the appropriate Alternative Term(s) to your account
    • Categories at the bottom of the page can also be used to find Alternative Terms via the hierarchical categorisation tool
    • An export file with the Obsolete and Alternative Terms is also available for download – please click on the Obsolete button on the My Terms page
    Basic Members:
    • Please search for Obsolete GMDN Codes or Term Names in the Search page here https://members.gmdnagency.org/Terms/Search
    • Click on Advanced to include Obsolete Terms in your search
    • By clicking on Details, you will be taken to the Obsolete Term details page where you will find the list of suggested Alternative Term(s) at the bottom of the page
    • An export file with the Obsolete and Alternative Terms is also available for download – please click on the Obsolete button on the Search page
  • Who decides on GMDN Term obsoletions, amendments and the need for adding a new GMDN Term?
    The GMDN Agency has a team of technical experts who create descriptions for medical devices. They follow a process to ensure the language used is clear and consistent.

    New products need to be added to the existing set of descriptions in a way that prevents duplication of Terms. If a product is truly unique, it is straightforward to add a new Term. If a new product is a variant of an existing product, an amendment may be allowed, but only if the scope of the Term is not reduced.

    Occasionally, the GMDN Agency may need to review Terms to ensure they are up to date with current technology. If a Term is no longer relevant, it may be made obsolete. Obsolete Terms remain available for reference purposes.
  • What is the process and Quality Management Systems for these changes?
    Updating of the GMDN Database is monitored and controlled by an ISO9001 Quality Management System. Our QMS is annually audited by a third-party Certification Body. GMDN Agency has been certified by BSI to ISO 9001:2015 under certificate number FS 639464. Our certification can be authenticated on the BSI Directory of Certified Clients. The GMDN Agency has internal QMS and SOPs regarding Term development, management of enquiries, and management of conflicts.
  • What if I can't find a GMDN Term for my product?
    If you can't find a GMDN Term that is appropriate for your product, you can request assistance from the GMDN Agency. We have a free online enquiry service that will review your product and the relevant existing GMDN Terms. The GMDN Agency will review your request and determine if a new GMDN Term is required or an existing GMDN Term may need to be modified or an existing GMDN Term may be suitable. When sending an enquiry, please include as much information about the product as possible. The enquiry process is complex and can take several weeks to complete, so please give us plenty of time to consider your enquiry. But please let us know if your need is urgent. You can raise an enquiry at this link.
  • What if I urgently need to register my product and can't find a suitable GMDN Code?
    Regulators and Conformity Assessment Bodies know the process for new Term requests used by the GMDN Agency and may accept a delay in providing a GMDN Code depending on their individual requirements, provided an enquiry for a new Term has already been made. Please let us know if your enquiry is delaying your product registration and we will try to assist.
  • Can anyone see the GMDN Codes I have chosen?
    All client information contained in the GMDN Database is password protected, encrypted and not available to any other member. Under strict controls we are required to share some client information with Medical Device Regulators, including the identification of GMDN Codes selected by Manufacturers and which appear in the 'My Terms' list.
  • Can I see all the GMDN Codes?
    The GMDN Codes are protected so that most members can only see Codes relevant to their product range. This is done by the member searching the GMDN Database until they find the most appropriate GMDN Term for their product. Members can see all 24,000+ GMDN Terms in the database. The member can then use a GMDN Code Credit to reveal the related GMDN Code (this is a 5-digit number). We provide all basic member accounts with 25 GMDN Code Credits when you join. Other membership types have more GMDN Code Credits, you can view our membership types at this link.
  • What is a GMDN Code Credit?
    “Code Credits” are for Basic members and paid Manufacturer and Consultancy or Commercial Organisation members, Code Credits are included with your GMDN membership. These allow you to reveal the appropriate GMDN Term Codes for your devices (One Code per Code Credit). If you are a paid Manufacturer and Consultancy or Commercial Organisation member, these GMDN Term Codes will be added to your account, and you’ll receive updates regarding any future changes to these GMDN Term Codes.

    If you run out of Code Credits, please contact us.
  • What if I want to share the GMDN access across my organisation?
    Multi-user access is managed within the GMDN Database by the 'Users' function, found in the 'Account' menu. The Users function is restricted to users with a specific permission on their GMDN membership account and may also be restricted by account type - please contact us for more information.
  • What if I choose the wrong GMDN Code?
    If a member wishes to change the GMDN Code selected for a particular product, it is recommended that they discuss this with their Regulator or Conformity Assessment Body. Please contact us if you have any concerns. If members no longer want us to monitor a Term in their 'My Terms' list, this can be moved to their 'My Archive' list.
  • Who is responsible for “Term Assignment”, and what does the GMDN do to ensure correct Term Assignment?
    The Manufacturer is responsible for assigning the correct GMDN Term to their device because they understand their device most comprehensively. The GMDN Agency provides training to Manufacturers through an online module, user guides, webinars, and a code of good practice. The GMDN has also built a new tool to help manufacturers find replacement Terms when a Term becomes obsolete. The GMDN provides feedback on assignments to Manufacturers through its membership contacts and supports them through the GMDN enquiry service.
  • Is the GMDN available in other languages?

    Languages supported in the GMDN

     

    As a global organisation the GMDN Agency supports several language translations in respect of GMDN Categories and Terms.

     

    Our supported languages are listed below.

     

    GMDN Categories Translations

    1. Arabic - اللغة العربية (In development)
    2. Brazilian Portuguese – Português do Brasil
    3. Chinese (Simplified) - 中文
    4. Danish - Dansk
    5. Dutch – Nederlands
    6. English - English
    7. French - Français
    8. German - Deutsch
    9. Italian - Italiano
    10. Japanese -日本語
    11. Norwegian - Norsk
    12. Polish – Polski
    13. Russian - Русский
    14. Spanish - Español
    15. Swedish - Svenska

    GMDN Categories translations are available for the above supported languages.

     

    GMDN Terms Translations

    1. Brazilian Portuguese – Português do Brasil
    2. English - English
    3. French – Français
    4. Russian - Русский
    5. Spanish - Español

    GMDN Terms translations are available for the above supported languages.

     

    They can be viewed on the Term Details and Explorer pages via the Advanced search functionality.

     

    Full available translation datasets for selected languages may also be obtained via our file sharing FTP service. Please contact us for more information.

     

    Additional languages

     

    There are available historical translations for additional languages (EU languages, Traditional Chinese).

     

    Please contact us for more information.

  • When a GMDN Term is modified or made obsolete will I have to reallocate the UDI on my product and re-label?
    GMDN Codes are not built into the Static UDI number allocated to your product and therefore changes to GMDN Terms will not require you to assign a new UDI to your product and the costly relabelling that would result.

    As part of their implementation of UDI, the US FDA require manufacturers to submit a GMDN Code that is not obsolete, when you provide your product information as part of the GUDID record submission. We have been informed by the FDA that it is possible to change the GMDN Code allocated to a product on the GUDID at any time, because the GMDN record is not ‘locked’ unlike other information, such as the Static UDI number.
  • If a product has a GMDN Code is it a Medical Device?
    If a product has been assigned a GMDN Code it is not necessarily a medical device. Please refer to the regulation that applies to medical devices in your country of interest. It is envisaged that the use of the GMDN by all countries will support the harmonisation of the definition of a medical device worldwide.
  • What are the changes regarding GMDN Codes and FDA PT Codes in GUDID?
    The FDA/NLM is adding new functionality to AccessGUDID and OpenFDA as regards the GMDN, namely that the GMDN Code and status (active or obsolete) will be displayed against each product record (along with the currently displayed name and definition). The FDA state: “If a labeller submitted an FDA Preferred Term (FDA PT) Code to meet their GMDN Code data entry requirement, the equivalent GMDN Code will now also be released publicly”. So, following this launch PT code users can register with GMDN and switch to using the GMDN Code. If you want to check the status of the GMDN Terms that you are using (and find the corresponding GMDN Codes by linking to your account) prior to the new AccessGUDID launch, then you can search the GMDN Database using the GMDN Term Name. Simply:
    • Register with GMDN
    • In search click ‘Advanced’ and ‘Include Obsolete’
    • Enter the Term Name and search
  • Can we put the GMDN Names, Definitions or Codes on the product packaging?
    No, the GMDN is not intended to be on the packaging for several important reasons. The definitions are in depth, the GMDN is published in over 25 languages, and it would take up too much space on the packaging. Also, these technical descriptions are subject to change over time as new medical innovations become available and are therefore dynamic in nature.
  • How do I differentiate between IVDs (in vitro diagnostics) and non-IVDs in the GMDN Database?
    Any Term within the GMDN Database that relates to an IVD will have IVD in the Term Name and will be grouped under the GMDN Category CT954 In vitro diagnostic medical devices (IVDs); all other Terms are non-IVDs.
  • We are a Distributor of medical devices, how can we get GMDN Codes for the products we stock?
    We recommend you talk to your suppliers and get the relevant GMDN Terms and Codes from them. This will make sure the GMDN Terms you use are consistent with other distributors in the market. Many manufacturers are licensee members of the GMDN Agency.
  • Can I get a matching EMDN Code from a GMDN Code?
    If you are a Manufacturer that needs an EMDN Code for registering a product in the EC EUDAMED database, you may find our "EMDN Service" useful to get ‘best match’ suggestions from your GMDN Codes.

    The "EMDN Service" provides GMDN members that have a 'paid-for' account membership with an EMDN Code for each GMDN Code listed in their 'My Terms'.

    Log in to access: https://members.gmdnagency.org/Terms/MyTerms

    The 'EMDN' button will provide a table with a one-to-one ‘best match’ suggestion. This service does come with a warning that all EMDN Codes should be carefully reviewed, based on the latest version of EMDN, before submission to EUDAMED.

    A full set of EMDN Terms can be downloaded from the European Commission website: https://webgate.ec.europa.eu/dyna2/emdn/

    Please note: EMDN Terms are typically drafted more widely than GMDN Terms, so products falling within different GMDN Terms may be covered by the same EMDN Term.

    The GMDN Agency last updated our EMDN Service in March 2022. We will no longer be updating this service going forward.

    The GMDN Agency has no responsibility or liability to you for use of any EMDN Term that is identified by this service - it remains your responsibility to ensure you use the most appropriate EMDN Term for the relevant medical device. For further assistance please contact the GMDN Agency.
  • If I have an EMDN Code obtained from a GMDN Code, is it necessary to continue with my GMDN Codes in Europe?
    Although the GMDN Code is not mandated in EUDAMED it is the decision of the Manufacturer whether to continue with your GMDN Codes. Stakeholders within the European Union, including some Regulators, may still require GMDN Codes. Also, more than 70 countries Regulatory bodies across the world use GMDN in some capacity regarding medical devices.
  • Who pays the bank fees/charges when transferring money to pay for GMDN membership?
    Please note that when paying for GMDN membership that the payee (member) is responsible for all bank fees/charges when transferring money to the GMDN Agency from overseas.
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