EUDAMED in numbers: 45% of active manufacturers had no device registered (September 2026)
Of 31,191 active manufacturers in EUDAMED's public data on 17 September 2026, 14,049 (45%) had no device registration. Counts by country, method and limits.
On 17 September 2026 the public EUDAMED data listed 31,191 active manufacturers. 14,049 of them, 45.0%, had no device registration at all: no Regulation device, no system or procedure pack and no legacy device. We counted every manufacturer and every one of the 3,503,902 device records the public data held that day.
That does not mean 14,049 manufacturers are late. Some have nothing to register, and some registrations are not public yet; the section on limits explains both. It does show how much registration work is still open ten weeks before the 28 November 2026 deadline for devices already on the market.
The numbers
| Active manufacturers | Count | Share |
|---|---|---|
| With Regulation devices or system/procedure packs | 14,904 | 47.8% |
| With legacy devices only | 2,238 | 7.2% |
| With no device registration | 14,049 | 45.0% |
| Total | 31,191 | 100% |
A further 1,119 manufacturers had the status "Inactive" and are not counted above.
By country
The 15 countries with the most active manufacturers that had no device registration:
| Country | No device registration | Active manufacturers | Share |
|---|---|---|---|
| China | 2,815 | 7,446 | 37.8% |
| Germany | 1,537 | 3,303 | 46.5% |
| Italy | 1,431 | 2,695 | 53.1% |
| United States | 1,027 | 2,432 | 42.2% |
| France | 815 | 1,713 | 47.6% |
| Türkiye | 582 | 1,095 | 53.2% |
| Netherlands | 564 | 1,043 | 54.1% |
| South Korea | 445 | 979 | 45.5% |
| United Kingdom (excluding Northern Ireland) | 396 | 1,031 | 38.4% |
| Pakistan | 372 | 524 | 71.0% |
| Poland | 368 | 789 | 46.6% |
| Spain | 340 | 786 | 43.3% |
| Sweden | 273 | 620 | 44.0% |
| India | 265 | 499 | 53.1% |
| Switzerland | 193 | 521 | 37.0% |
Inside the EU, 6,748 of 13,977 active manufacturers (48.3%) had no device registration; outside it, 7,301 of 17,214 (42.4%). The manufacturers came from 109 countries.
What the numbers do not say
- Not every manufacturer has something to register. Custom-made and investigational devices, and devices for performance studies, are not registered in the UDI/device module. Devices no longer placed on the market when registration became mandatory need no registration unless a vigilance action concerns them. A legacy device needs none if the same device is registered as a Regulation device.
- Some registrations are not public yet. For certain devices the Commission states that the UDI and device data become visible to the public only once the notified body has entered the certificate information. A manufacturer can therefore have registered devices that the public data does not show.
- It is one moment. Manufacturers were read on 16 September 2026 (20:38 to 20:39 UTC) and device records on 17 September 2026 (04:17 to 06:23 UTC). Registrations made later are not included.
- Producers of systems and procedure packs (645 SRNs) are outside the count, which covers manufacturers only.
How we counted
- Source: the public EUDAMED data service of the European Commission (
api.datalake.sante.service.ec.europa.eu/eudamed): every manufacturer from the actors data (ACTOR_TYPE=Manufacturer, 39 pages) and every device record from the UDI data (3,504 pages). - Active: the manufacturer's status in EUDAMED is "Active".
- No device registration: not a single device record carries the manufacturer's SRN, whatever the device type, legacy devices included.
- Checks on the count: - an independent database recount gave the same totals; - all 3,504 pages were read without a gap, with one duplicate record; - live look-ups in EUDAMED agreed for every manufacturer sampled: 150 of 150 on 16 September, then 100 of 100 from the "no device" group and 50 of 50 from the others on 17 September, device counts included; - with no error in 193 sampled "no device" manufacturers, the error rate of that group is below 1.6% at 95% confidence.
We publish only totals. The data comes from the European Commission's public EUDAMED database; the counting is ours.
Sources
- European Commission, EUDAMED public data, read on 16 and 17 September 2026.
- European Commission, Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed, questions 7 and 8 (who registers what, and public visibility).
- Regulation (EU) 2024/1860 and Commission Decision (EU) 2025/2371 (the deadlines).