EUDAMED insights
EUDAMED Insights
Device, manufacturer, risk class, legislation and representative visibility over a limited EUDAMED dataset that is growing in a controlled way.
Report date: Oct 13, 2026, 9:08 PM · Source: EUDAMED public data, utsbridge.com/eudamed/reports
Upcoming Certificate Expiries
EUDAMED certificates whose validity ends within the selected window. Soonest expiries are listed first.
Device Data Coverage
Shows the current size of the dataset, manufacturer coverage and key fill rates.
Representative coverage, non-EU manufacturers
1,860,315 / 1,876,247
EMDN fill rate
4,021,364 / 4,128,185
Total devices
4,128,185
Public EUDAMED device records (UDI-DI).
Visible manufacturers
18,703
Distinct manufacturer SRN count
Representative coverage, non-EU manufacturers
99.2%
1860315 / 1876247 devices show a representative
EMDN fill rate
97.4%
5667 distinct EMDN codes are visible
Device distributions
Risk class and device status summarised across device records.
Risk class
Device status
Manufacturer and AR Visibility
Top manufacturers and authorised representatives are bounded to 10 rows.
Leading manufacturers
Leading authorised representatives
Market Intelligence
Shows EMDN concentration, country visibility and EUDAMED family registration activity at a glance.
Leading EMDN codes
Country visibility
EUDAMED registration activity
Certificate Validity View
Summarises certificate records by validity end date and notified body.
Certificate records
3,479
Total certificate records in the search index.
Records past end date
78
Records whose validity end date is before today.
Expiring in 90 days
47
Records whose validity end date falls in the next 90 days.
Certificate status
Leading notified bodies
Ready Reports
Readable market, competition, regulatory and data health reports generated from the current EUDAMED dataset.
EUDAMED Registration Activity Report
Finding
In the last 30 days 95,768 device families were registered in EUDAMED for the first time and 542 families had their registration updated (based on 958,427 / 1,114,296 device families with version data). The densest EMDN is M030405; the most visible country is DE.
Impact
Most activity is new family registrations: new products are being registered in EUDAMED. Registration does not mean the product has been placed on the market.
Action
Filter the densest EMDN code and country and review the manufacturers registering new families.
Evidence
Families first registered in 30 days
95,768
based on 958,427 / 1,114,296 device families with version data
Families updated in 30 days
542
Leading EMDN codes
M030405 - 313,448 / 7.6%
Country visibility
DE - 1,631,041 actor/device links
Authorised Representative and Country Report
Finding
Of the 1,876,247 devices from manufacturers that must appoint an authorised representative (outside the EU, EEA and Turkey), 99.2% show one; 15,932 do not. The most visible country is DE.
Impact
Most devices from non-EU manufacturers show a representative. EU, EEA and Turkish manufacturers do not need one.
Action
Use the country filter to separate target markets and review the representative network directly.
Evidence
Representative coverage, non-EU manufacturers
99.2%
1860315 / 1876247 devices show a representative
Devices with no visible representative (non-EU manufacturer)
15,932
Country visibility
DE
DE - 1,631,041 actor/device links
Manufacturer / representative country split
924,697 manufacturer country / 706,344 representative country
Competitive Visibility Report
Finding
The leading manufacturer is Ofa Bamberg GmbH (88,213 devices). The leading authorised representative is Obelis s.a. (207,879 devices).
Impact
Devices are spread across many manufacturers; this is a fragmented, competitive market.
Action
Cluster niche manufacturers by EMDN and country and look for gaps in the fragmented market.
Evidence
Leading manufacturers
Ofa Bamberg GmbH - 88,213 devices
Class I / MDR 2017/745
Leading authorised representatives
Obelis s.a. - 207,879 devices
Class IIa / MDR 2017/745
Certificate Validity Report
Finding
78 certificate records are past their validity end date and 47 reach it within 90 days. The notified body with the most visible certificates: NB 0197.
Impact
A record past its end date does not mean the certificate was not renewed; a renewed certificate can be published in EUDAMED as a separate record.
Action
Check the manufacturer’s current certificate record in EUDAMED.
Evidence
Certificate records
3,479
Records past end date
78
Expiring in 90 days
47
Leading notified bodies
NB 0197 - 558 certificates
Data Health Report
Finding
EMDN fill rate is 97.4%; 106,821 devices have no EMDN code. Last device update is Oct 13, 2026, 9:00 PM.
Impact
Core field coverage is high; category and company analyses can be trusted.
Action
Category and company analyses can be used directly.
Evidence
Total devices
4,128,185
EMDN fill rate
97.4%
106,821 devices have no EMDN
Representative coverage, non-EU manufacturers
99.2%
15,932 devices from non-EU manufacturers show no representative
Last device update
Oct 13, 2026, 9:00 PM
Device Status Report
Finding
Dominant device status is On market (4,038,989 / 97.8%).
Impact
The dominant device status is “active”; most of the portfolio is registered as active in EUDAMED.
Action
Focus on the active portfolio and deepen this segment with the visibility and competition reports.
Evidence
Device status
On market - 4,038,989 / 97.8%
Data Notes
Certificate and actor coverage is shown as a data maturity note, not as the main report promise.
Certificate records
3,479
Certificate coverage is expanding through controlled backfill.
Actor records
48,058
Actor coverage supports manufacturer and representative visibility.
Last device update
Oct 13, 2026, 9:00 PM
Latest update time for device data coverage.