European Union device registration in numbers: 1,838 companies, 150,958 UDI-DI device records

This note covers a single market — European Union. The official source is EUDAMED. How many companies and records the database holds here, how classes break down, what share is Chinese, and how to read the figures. Data as of 2026-09-07.

What the database holds here

In European Union, 1,838 companies have records, 150,958 UDI-DI device records in total, averaging 82.1 each. By company location: China 1,222, Germany 96, Italy 58, USA 46, 未标注 44, Taiwan 38.

1,260 of those companies are from mainland China, Hong Kong, Taiwan or Macau (69%). 952 of the companies here also hold records in five or more markets, which is the multi-market group.

Class distribution

class-i 69,396, class-iia 45,342, class-iib 12,846, ivd-general 9,741, class-a 6,011, class-iii 4,141, class-b 1,321, class-c 1,229. Note: where a result set is large only the first 300 records are verified, so figures are lower bounds.

Class fields are defined differently in each jurisdiction and do not map across markets: EU Class IIa/IIb is not the same thing as China Class II, and the evidence route for US Class II differs from EU Class IIa. Which column each class figure is taken from is listed at the methodology page.

Companies with the most records

Company	Country	UDI-DI device records	Markets
3K LABORATUVAR MEDİKAL PLASTİK LTD.ŞTİ.	Türkiye	300	2
Agilent Technologies GmbH	Germany	300	11
Alerta Medical Ltd.	United Kingdom of Great Britain and Northern Ireland	300	5
Anhui Tiankang Medical Technology Co., Ltd	China	300	10
Argon Medical Devices, Inc.	USA	300	12
ARIES a.s.	Czechia	300	2
Asahi Intecc Co., Ltd.	Hong Kong, China SAR	300	12
Bahadır Tıbbi Alet Cihaz ve İnşaat Makina San. ve Tic. A.Ş.	Türkiye	300	2
Bain Medical Equipment (Guangzhou) Co., Ltd.	China	300	13
BARNA IMPORT MEDICA S.A.	Spain	300	2
BATIST Medical a.s.	Czechia	300	1
Batrik Medical Manufacturing, Inc.	Canada	300	9

How much was excluded during verification

In this market the database excluded 63,059 records that matched by name but belong to different companies. The exclusion volume is itself a data-quality signal: the more that is excluded, the looser the registry search interface, and the larger the error from using raw hit counts.

How to verify this yourself

Every market figure on this site is the result of **re-checking each manufacturer name record by record**, not a raw hit count from a registry search interface. Name search in these registries is generally a substring match: searching EUDAMED for "Edan" returns 1,933 records, of which 434 belong to HANEDAN in Turkey and 300 to TeDan Surgical in the United States — taking the raw count would overstate by more than 60 percent. We therefore require the distinctive token to appear as a whole word and demand a genuinely distinguishing shared token; generic words such as "medical" or "systems" never qualify on their own, and the similar names that were excluded are listed on each company page. Each market counts a different unit (the EU counts UDI-DI device records, the US counts listed device types, Canada and Brazil count valid registrations, Korea counts quality-system certifications), so figures cannot be summed or compared across markets. The full basis, official portals and query paths are at the methodology page.

This database; source data from EUDAMED