EUDAMED insights
EUDAMED Insights
Device, manufacturer, risk class, legislation and representative visibility over a limited EUDAMED dataset that is growing in a controlled way.
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 fill rate
1,377,883 / 2,830,920
EMDN fill rate
2,393,195 / 2,830,920
Total devices
2,830,920
Device records in the controlled EUDAMED seed dataset.
Visible manufacturers
16,589
Distinct manufacturer SRN count
Representative fill rate
48.7%
1377883 devices have representative data
EMDN fill rate
84.5%
5249 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 recent movement at a glance.
Leading EMDN codes
Country visibility
Record activity
Certificate Risk View
Summarises certificate coverage, validity risk and notified body concentration.
Certificate records
3,100
Total certificate records in the search index.
Expired certificates
45
Records whose validity end date is before today.
Expiring in 90 days
32
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.
Market Opportunity Report
Finding
There are 354,518 new devices and 1,867,560 updates in the last 30 days. The densest EMDN signal is Y063303; the leading country signal is DE.
Impact
Most movement is updates to existing records; this is portfolio revision, not new entry.
Action
Focus on updated records and track portfolio and label changes from existing players.
Evidence
New devices in 30 days
354,518
Updated in 30 days
1,867,560
Leading EMDN codes
Y063303 - 137,791 / 4.9%
Country visibility
DE - 988,063 actor/device links
Country and Representation Report
Finding
Authorised representative fill rate is 48.7%. 1,453,037 devices have no representative link; the leading country signal is DE.
Impact
More than half of devices have no authorised representative link; country and representative analysis runs on incomplete data right now.
Action
Prioritise devices missing a representative link for enrichment first; trust the country breakdown only afterwards.
Evidence
Representative fill rate
48.7%
1377883 devices have representative data
Devices without representative link
1,453,037
Country visibility
DE
DE - 988,063 actor/device links
Manufacturer / representative country split
480,536 manufacturer country / 507,527 representative country
Competitive Visibility Report
Finding
The leading manufacturer is Schein Orthopädie Service KG (60,727 devices). The leading authorised representative is Obelis s.a. (190,520 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
Schein Orthopädie Service KG - 60,727 devices
Class I / Not specified
Leading authorised representatives
Obelis s.a. - 190,520 devices
Class IIa / MDR 2017/745
Certificate Risk Report
Finding
45 certificates are expired and 32 expire within 90 days. Notified body concentration: NB 0197.
Impact
There are expired certificates; the EU-market compliance of the linked devices is directly at risk.
Action
Flag devices with expired certificates via company and device search; verify before any supply decision.
Evidence
Certificate records
3,100
Expired certificates
45
Expiring in 90 days
32
Leading notified bodies
NB 0197 - 558 certificates
Data Health Report
Finding
EMDN fill rate is 84.5%; 437,725 devices have no EMDN code. Last device update is Jul 16, 2026, 5:08 PM.
Impact
EMDN or representative coverage is low; category and company breakdowns may be misleading right now.
Action
Give enrichment worker priority to records missing EMDN and representative links; re-assess the reports afterwards.
Evidence
Total devices
2,830,920
EMDN fill rate
84.5%
437,725 devices have no EMDN
Representative fill rate
48.7%
1,453,037 devices have no representative link
Last device update
Jul 16, 2026, 5:08 PM
Device Status Report
Finding
Dominant device status is On market (2,776,612 / 98.1%).
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 - 2,776,612 / 98.1%
Data Notes
Certificate and actor coverage is shown as a data maturity note, not as the main report promise.
Certificate records
3,100
Certificate coverage is expanding through controlled backfill.
Actor records
47,410
Actor coverage supports manufacturer and representative visibility.
Last device update
Jul 16, 2026, 5:08 PM
Latest update time for device data coverage.