Australia device registration in numbers: 6,591 companies, 48,531 active ARTG entries

This note covers a single market — Australia. The official source is TGA ARTG. 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 Australia, 6,591 companies have records, 48,531 active ARTG entries in total, averaging 7.4 each. By company location: USA 1,816, China 1,265, Germany 580, 未标注 400, United Kingdom of Great Britain and Northern Ireland 278, Korea, Republic 246.

1,424 of those companies are from mainland China, Hong Kong, Taiwan or Macau (22%). 3,344 of the companies here also hold records in five or more markets, which is the multi-market group.

Class distribution

I 20,821, IIa 11,979, IIb 6,122, III 4,558, Is 2,073, 2 990, 1 701, 3 677.

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	active ARTG entries	Markets
ZIMMER PTE. LTD.	Singapore	1,394	9
Abbott Medical	USA	424	11
Smith & Nephew Medical (Shanghai) Limited	China	418	12
Biomet Orthopedics, Inc.	USA	337	11
Arthrex, Inc.	USA	317	11
Boston Scientific Corporation -	USA	316	11
Synthes, Inc.	Switzerland	302	11
HOWMEDICA OSTEONICS CORPORATION	USA	298	5
COCHLEAR LIMITED	Australia	277	11
KLS Martin SE & Co. KG	Germany	273	10
AESCULAP, INC.	Germany	261	11
Depuy Ireland UC	Ireland	236	11

How much was excluded during verification

Matching in this market runs against a bulk export compared locally, with verification performed at import time.

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 TGA ARTG