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

12,030

Device records in the controlled EUDAMED seed dataset.

Visible manufacturers

815

Distinct manufacturer SRN count

Representative fill rate

71.1%

8548 devices have representative data

EMDN fill rate

89%

1002 distinct EMDN codes are visible

Risk Class and Legislation Distribution

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

Risk class

Class I4,452 / 37%
Class IIa3,945 / 32.8%
Class IIb1,649 / 13.7%
General IVD679 / 5.6%
Class III673 / 5.6%

Legislation

Not specified12,030 / 100%

Manufacturer and AR Visibility

Top manufacturers and authorised representatives are bounded to 10 rows.

Leading manufacturers

Daddy D Pro

PK-MF-000035172 - 1013 devices

Class INot specified

Medos International SARL

CH-MF-000014268 - 317 devices

Class INot specified

Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG

DE-MF-000012472 - 249 devices

Class IIbNot specified

Hangzhou Tappa Medical Technology Co , Ltd.

CN-MF-000027753 - 178 devices

Class IIaNot specified

Chongqing FWS Medical Device Co.,Ltd

CN-MF-000008972 - 151 devices

Class IIbNot specified

Leading authorised representatives

ANTEX MEDI SOLUTION

DE-AR-000008078 - 1718 devices

Class INot specified

Obelis s.a.

BE-AR-000000106 - 785 devices

Class IIaNot specified

Emergo Europe B.V.

NL-AR-000000116 - 570 devices

Class IIaNot specified

Shanghai International Holding Corp. GmbH(Europe)

DE-AR-000000001 - 563 devices

Class IIaNot specified

DePuy Ireland UC

IE-AR-000009328 - 421 devices

Class INot specified

Device and Market Status Summary

Shows the distribution of device status and market status fields.

Device status

On market11,389 / 94.7%
Not intended for the EU market351 / 2.9%
No longer on market290 / 2.4%

Market status

Not specified12,030 / 100%

Data Notes

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

Certificate records

230

Certificate coverage is expanding through controlled backfill.

Actor records

1,671

Actor coverage supports manufacturer and representative visibility.

Last device update

May 23, 2026, 12:12 PM

Latest update time for device data coverage.