List of Global Medical Device Nomenclature (GMDN) Codes

LievenDW

Involved In Discussions
#11
As far as I know you have to become a member of GMDN to access the codes, and it is not allowed for members to distribute the codes. However, the high membership fees don't make it very attractive to apply for it.
 
Elsmar Forum Sponsor
M

MirekJ

#12
GMDN agency has a good lobbying, so please acclimate to universal application of GMDN codes. Almost all Notified Bodies in Europe have started with using codes. It is bad information for manufactures and distributors - high costs - for me it is next tax.
 
S

SuzieShu

#13
I have a friend who wants to get the GMDN code, as far as we know, the code is restricted with the manufactuer and the product so the porduct can be easily traced through this GMDN code, while in GMDN agency website, we found that a lot of codes are listed and after we pay the membership fee, we have the access, then it means it only relates to product,not manufactuer, so can you please help me on clarifying this?Thanks!
 
S

SteveK

#14
Hi Suzie,

The GMDN code is for the particular product type. However, the wording/definition relating to a particular code number can change over time (or be made obsolescent). As a manufacturer, if you are a member of GMDN they will inform you of the change (I have emails from the GMDN agency to this effect – the changes can be very subtle though!) - or you can track changes on the site (as a member). Obviously, if you acquired a number by other means (i.e. not as a member) you will probably be unaware of this. On the TGA site for example, some of the devices registered that I have looked at often indicate an out of date GMDN number – correct at the time of registration though, so I do not know if this is an issue with a particular regulatory body.:2cents:

Steve
 
R

remekim

#15
I have found several lists of GMDN codes, but I still can't find codes of 35389 and 45042.
Why? Who can help me ?
I attaching a list of GMDN codes as an example.
Hello!
I'm new in this forum. I have download your GMDN list but I would need the codes from 44688 to 51084 more or less. Please, could you tell me where can I found??
Thank you in advance.
 

LievenDW

Involved In Discussions
#16
GMDNS Definition : Syringe, hypodermic, insulin[35389]

A device with a small barrel with plunger, calibrated in units of insulin, used with a needle to administer (infuse) insulin subcutaneously.

Primary Code and Term
35389 - Syringe, hypodermic, insulin

GMDNS Definition : Syringe, hypodermic, metered delivery, retractable needle[45042]

A device with a retractable needle that has the same function as a standard hypodermic syringe with an attached needle. This device has a graduated barrel with plunger designed to deliver (infuse) an accurate metered dosage of a substance (medicine/drug) throughout the administration of an injection. Incorporated in the design is a needle retraction mechanism allowing the needle to be shielded (e.g., retracted into the syringe barrel and secured there) to protect personnel/people from sharps injuries. This is a single-use device, which can be used by healthcare personnel or the public.

Primary Code and Term
45042 - Syringe, hypodermic, metered delivery, retractable needle
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#18
A quick "Bump". Can anyone help with this one? Please - Help if you can. My Thanks in advance!
 
A

a friend

#19
Brief Summary:

The 12 categories in the GMDN (Global Medical Device Nomenclature) Code table are:
Code Term
01 Active implantable devices
02 Anaesthetic and respiratory devices
03 Dental devices
04 Electro-mechanical devices
05 Hospital hardware
06 In vitro diagnostic devices
07 Non-active implantable devices
08 Ophthalmic and optical devices
09 Reusable instruments
10 Single use devices
11 Technical aids for disabled persons
12 Diagnostic and therapeutic radiation devices

Preferred terms represent a type of device that has the same or similar intended purpose or common technology. Eg: forceps bone, forceps biopsy, forceps lung.

It is important to ensure that the definition of a preferred term accurately describes the device. If not an alternative search may be needed to find the most appropriate GMDN term for the device.

Class I devices that have a measuring function or are supplied sterile, Class IIa and Class IIb medical devices are identified and included on the ARTG by the preferred term.

Class III and Active Implantable Devices (AIMDs) are identified and included on the ARTG using the preferred terms and an additional unique product identifier. This additional identifier is not part of the GMDN Coding system and is issued by the manufacturer to describe a device and any variants of the device that provide for different patient anatomy.

Hi ! :agree:

Could you please help me to find the UMDNS for a Dental device . This Dental device is Dental Diamond Burr .

1 - It is being manufactured in many shapes & types . Does a UMDNS code determines for all types & shapes or does it have just one Code for all Dental Burrs ?

2 - What is UMDNS Code for Blank shanks of this Device before coating with diamonds ? For your information This device after diamond coating is being named as Burr but before it is being called shank .

3 - Is it the same as GMDN Coding system ?

Thank you so much for you help .:thanx:
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#20
I hope someone can help with this, but this is an old thread and it is rare that anyone in the dental industry stops by here. Just a "heads up".

If anyone can help out with this one, as always - My Thanks in advance.
 
Thread starter Similar threads Forum Replies Date
S Compliance to GADSL (Global Automotive Declarable Substance List) RoHS, REACH, ELV, IMDS and Restricted Substances 4
Kales Veggie Global Automotive Declarable Substance List (GADSL) 2009 released..... Miscellaneous Environmental Standards and EMS Related Discussions 2
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
bryan willemot Looking for an Approved vendors list template Document Control Systems, Procedures, Forms and Templates 11
U Approved Vendor (supplier) List Supplier Quality Assurance and other Supplier Issues 8
M Management review check-list Management Review Meetings and related Processes 3
lanley liao How to correctly understand the bullet list d) of 6.3 Analysis of Data for API Spec Q1 Oil and Gas Industry Standards and Regulations 7
D Approved supplier list - Distributors question ISO 13485:2016 - Medical Device Quality Management Systems 6
lanley liao How to understand this bulleted list from API 600 Oil and Gas Industry Standards and Regulations 0
D Approved supplier list for R&D ISO 13485:2016 - Medical Device Quality Management Systems 5
R Qualification list of businesses approved to Off-Shore Aerospace work. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
F List of countries that 'prefer' a CE Mark CE Marking (Conformité Européene) / CB Scheme 1
C List of MDSAP Auditing Organizations Medical Device and FDA Regulations and Standards News 1
G MSA check list to audit IATF 16949 - Automotive Quality Systems Standard 10
D List A IVD - Change to material supplier EU Medical Device Regulations 3
M Sites to List on Multi-Site Certifications Registrars and Notified Bodies 1
D How to list multi-product sample pack in GUDID 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
G Free Sales certificates for Medical Devices - List of countries EU Medical Device Regulations 4
dgrainger Informational EU published new Harmonised Standards List for the Directives (25/3/2020) Medical Device and FDA Regulations and Standards News 0
G Assignable cause/corrective action list for SPC Software Statistical Analysis Tools, Techniques and SPC 3
F ISO Certified companies - Is there a list of certified companies that I can access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q Forms Master List versus Record Matrix ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Why does Official Journal list superseded standards? EU Medical Device Regulations 6
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
K List of Deregulated Devices in Mexico Other Medical Device Regulations World-Wide 2
G Harmonized List - MDD 93/42/EEC Other ISO and International Standards and European Regulations 2
M EU – REACH Authorisation Decisions List REACH and RoHS Conversations 0
E Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
M Informational US FDA – Modifications to the List of Recognized Standards, Recognition List Number: 052 Medical Device and FDA Regulations and Standards News 0
Sidney Vianna Informational List of ISO Management System Standards Other ISO and International Standards and European Regulations 0
Q AS9120 Vendor of ESD Monitoring Equipment needs to be in the Approved Supplier List? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Informational EU – Candidate List of substances of very high concern for Authorisation Medical Device and FDA Regulations and Standards News 0
F List of approved API manufacturers or Formulations manufacturers US Food and Drug Administration (FDA) 0
P List of ISO certificate registrars around the world - ISO certification databases ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Informational US FDA – Priority List of Patient Preference-Sensitive Areas Medical Device and FDA Regulations and Standards News 0
S List of requirements for Management Review in IATF 16949 IATF 16949 - Automotive Quality Systems Standard 10
M IATF 16949 - 8.5.6.1.1 Providing a list of process controls: Does this requirement add value to QMS? IATF 16949 - Automotive Quality Systems Standard 4
R List of countries that require only CE Mark certificate for product registration Other ISO and International Standards and European Regulations 2
T Medical device Clinical trial exemption list China Medical Device Regulations 2
D China - Where I can get NMPA complete structure/organogram chart and GB/YY format list China Medical Device Regulations 1
M Informational USFDA – FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051 Medical Device and FDA Regulations and Standards News 0
eule del ayre List of Level 3 PPAP requirements for automotive suppliers APQP and PPAP 20
A What ISO 9001:2015 clause could be used to write nonconformance for not updating licensed driver list? General Auditing Discussions 8
M Is there a published List of AIAG members requiring IATF certification ? IATF 16949 - Automotive Quality Systems Standard 2
Marc Attachment List Update - 2018-11-16 Forum News and General Information 0
M Medical Device News EU - List of national market surveillance authorities by sector and country EU Medical Device Regulations 0
G Where to list chain of traceability? ISO 17025 related Discussions 6
M Medical Device News Health Canada - Proposed Changes - List of Recognized Standards for Medical Devices Canada Medical Device Regulations 3
F Design check list for Cable and Wiring Harnesses Manufacturing and Related Processes 6
P Template or example Excel list of ISO certificates issued to clients ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5

Similar threads

Top Bottom