EUDAMED insights

EUDAMED Insights

Device, manufacturer, risk class, legislation and representative visibility over a limited EUDAMED dataset that is growing in a controlled way.

These reports are generated from a controlled EUDAMED seed dataset that grows incrementally. Results update as coverage expands.

Device Data Coverage

Shows the current size of the dataset, manufacturer coverage and key fill rates.

Total devices

18,261

Device records in the controlled EUDAMED seed dataset.

Visible manufacturers

995

Distinct manufacturer SRN count

Representative fill rate

70.4%

12850 devices have representative data

EMDN fill rate

90.9%

1139 distinct EMDN codes are visible

Risk Class and Legislation Distribution

Summarises MDR, IVDR and risk class visibility across device records.

Risk class

Class I6,534 / 35.8%
Class IIa5,992 / 32.8%
Class IIb2,973 / 16.3%
Class III1,066 / 5.8%
General IVD881 / 4.8%

Legislation

Not specified18,261 / 100%

Manufacturer and AR Visibility

Top manufacturers and authorised representatives are bounded to 10 rows.

Leading manufacturers

Daddy D Pro

PK-MF-000035172 - 1244 devices

Class INot specified

Medos International SARL

CH-MF-000014268 - 565 devices

Class INot specified

Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG

DE-MF-000012472 - 416 devices

Class IIbNot specified

YAMAHACHI DENTAL MFG., CO.

JP-MF-000024849 - 318 devices

Class IIaNot specified

Chongqing FWS Medical Device Co.,Ltd

CN-MF-000008972 - 278 devices

Class IIbNot specified

Leading authorised representatives

ANTEX MEDI SOLUTION

DE-AR-000008078 - 2052 devices

Class INot specified

Obelis s.a.

BE-AR-000000106 - 1570 devices

Class IIaNot specified

Emergo Europe B.V.

NL-AR-000000116 - 929 devices

Class IIaNot specified

Shanghai International Holding Corp. GmbH(Europe)

DE-AR-000000001 - 837 devices

Class IIaNot specified

DePuy Ireland UC

IE-AR-000009328 - 669 devices

Class INot specified

Device and Market Status Summary

Shows the distribution of device status and market status fields.

Device status

On market17,470 / 95.7%
Not intended for the EU market399 / 2.2%
No longer on market392 / 2.1%

Market status

Not specified18,261 / 100%

Data Notes

Certificate and actor coverage is shown as a data maturity note, not as the main report promise.

Certificate records

525

Certificate coverage is expanding through controlled backfill.

Actor records

3,724

Actor coverage supports manufacturer and representative visibility.

Last device update

May 24, 2026, 10:56 AM

Latest update time for device data coverage.