This note uses our own data to map device registration in 湖南省, 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 101 companies in 湖南省 with Chinese registrations or filings, 1,584 certificates in total, ranking 10 among the provincial-level areas covered. That is 15.7 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: 520 Class I filings, 980 Class II and 82 Class III registrations. Class II and III together are 1,062 certificates, 67% 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. 湖南省 sits above the national average, which suggests a product mix weighted toward higher-risk classes and heavier registration and clinical-evaluation investment.

Companies holding the most certificates

CompanyChina registrations / filingsMarkets
Cofoe Medical Technology Co., Ltd.2008
Sinocare Inc.1702
HUNAN ZHEHEYIKANG MEDICAL INSTRUMENT CO.,LTD601
Hunan Reborn Medical Science and Technology Development Co.,Ltd.576
湖南巴德医药科技有限公司561
HUNAN PINGAN MEDICAL DEVICE TECHNOLOGY CO., LTD.472
Hunan Boko Medical Technology Co.,Ltd.451
湖南华联康生物科技有限公司391
ZHUZHOU MAOWU MEDICAL TREATMENT THCHNOLOGY CO., LTD371
HUNAN KMS MEDICAL TECHNOLOGY CO.,LTD353
邵阳智康医疗器械有限公司321
Hunan Endovascular Devices CO.,LTD313

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 101 companies recorded in 湖南省, 26 also have registrations outside China — 26%. By market: 欧盟 20, 巴西 12, 美国 8, 英国 8, 俄罗斯 7, 以色列 6.

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, 湖南省 concentrates in 中医定向透药治疗仪, Cofoe most hot sale Blood pressure monitors, Cofoe hot sale non contact infrared thermometer, Cofoe good price hot sale Nebulizer, Cofoe factory price hot sale hearing aids, Sunfusion®系列注射泵, ResGuard系列无创呼吸机, Sunfusion工作站FS3.

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