Methodology

Which companies are covered, where the figures come from, how they are verified.

Coverage

The database currently covers 102,040 medical device companies from two kinds of source: public exhibition listings (MEDICA / COMPAMED, CMEF) and manufacturers that appear in the national device registries but not in any exhibitor list — every company with a record in any connected registry gets an entry. Company name, country, city, website and product categories come from public sources. No personal names or personal mobile numbers are collected; such data is stripped before ingest.

Where the business-registry data comes from

For Chinese companies, incorporation date, registered capital, social-insurance headcount and registration status come from Tianyancha business-registry records (delivered per company by name and unified social credit code, with the code check digit verified). For companies elsewhere the source is the GLEIF LEI database (CC0 open data) and France’s INSEE Sirene; registration numbers, legal forms and registering authorities are resolved through the official code lists. No personal data (legal representatives, contacts, phone numbers, e-mail) is collected, and risk records are never published.

Where the figures come from

Registration counts are not estimates. They come from the regulators’ own public databases. 14 markets are connected: China (NMPA), European Union (EUDAMED), United States (FDA openFDA), United Kingdom (MHRA PARD), Brazil (ANVISA), Saudi Arabia (SFDA), Canada (MDALL), Taiwan (TFDA), Singapore (HSA SMDR), South Korea (MFDS GMP), Australia (TGA ARTG), Hong Kong (MDACS), Israel (AMAR), Russia (Roszdravnadzor). The portal, exact query path and search field for each market are listed in the table below.

Why every record is re-checked

Company-name search in these databases is a substring match and returns same-named but different companies. Measured: searching EUDAMED for "Edan" returns 1,933 raw hits, of which 434 belong to HANEDAN in Turkey and 300 to TeDan Surgical in the US — taking the raw count would overstate the figure by more than 60 percent. Every hit is therefore re-checked against the manufacturer name: the distinctive token must appear as a whole word and there must be a genuinely distinguishing shared token. Generic words such as "medical" or "systems" are never enough on their own. Excluded records are listed on each company page.

Units and limitations

Each market counts a different unit, so figures are not directly comparable: China counts China registrations; European Union counts UDI-DI device records; United States counts listed device types; United Kingdom counts registered device records; Brazil counts registered devices; Saudi Arabia counts registered imported devices; Canada counts active device licences; Taiwan counts valid device licences; Singapore counts device registrations; South Korea counts GMP quality-system certificates; Australia counts active ARTG entries; Hong Kong counts valid listings; Israel counts registrations; Russia counts active registrations. Where an EU result set is large only the first 300 records are verified and the figure is prefixed with an inequality sign. The Brazilian export covers Class I and II only; the Saudi file covers low-risk imported devices in a 2023 snapshot; Hong Kong MDACS is a voluntary listing scheme; the Korean file is GMP system certification, not per-device registration. On company pages "not queried" means the company has not yet been looked up in that market and "n/a" means the registry lists domestic registrants only. Missing data is shown as pending — never filled with estimates. Risk records are not published.

Updates and corrections

The source databases are updated continuously and this database is re-fetched in batches. If you find an incorrect figure or a wrong match, write to haixiao@sungolytest.com and we will re-check and correct it.

Official sources and query paths

Which official database each figure comes from, the exact query path, the search field and the class field.