This note uses our own data to map device registration in 山东省, China: how many companies, how many certificates, how the classes break down, which companies hold the most, and which overseas markets those companies reached. Data as of 2026-09-07.
Volume and rank
As of 2026-09-07 the database holds 271 companies in 山东省 with Chinese registrations or filings, 5,229 certificates in total, ranking 4 among the provincial-level areas covered. That is 19.3 certificates per company against a national average of 8.1 — above the national average, indicating a concentration of larger certificate holders.
What the class split shows
By class: 2,884 Class I filings, 1,666 Class II and 575 Class III registrations. Class II and III together are 2,241 certificates, 44% of the total, against 44% nationally.
Class I is a filing regime administered locally with a low barrier, so it dominates by count everywhere; comparing provinces on Class I volume tells you little. The share of Class II and III is the discriminating measure. 山东省 sits below the national average, which suggests a mix weighted toward lower-risk and filing-only products.
Companies holding the most certificates
The "Markets" column counts how many of the 14 official registries in this database return records for that company. Follow a company link to see per-market record counts, class distribution, and the similar names that were excluded during verification.
Overseas footprint
Of the 271 companies recorded in 山东省, 88 also have registrations outside China — 32%. By market: 欧盟 59, 美国 41, 巴西 37, 澳大利亚 26, 以色列 20, 英国 15.
Read that share with care: the Chinese side groups by company name and the overseas side verifies manufacturer names record by record. Where the two spellings differ the link fails, so "not found" does not mean "does not exist".
Product focus
By main product terms, 山东省 concentrates in 医用外科口罩, 一次性使用灭菌橡胶外科手套, 医用一次性防护服, 泡沫敷料, 电动手术台, 医用高分子夹板, 一次性使用静脉采血针, 一次性使用医用外科口罩.
How to read these numbers
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. Chinese data comes from NMPA public registration and filing records grouped by company name; filings map to Class I, provincial approvals to Class II and national approvals to Class III. 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.
Related
Related: All Chinese companies · Browse by market · Browse by category · Methodology and official query paths.
This database; Chinese figures from NMPA public registration and filing data