HomeChinaSinocare Inc.

Sinocare Inc.

China · 长沙 · www.sinocare.com
✓ Record-verifiedregistrations found in 2 marketsUnified social credit code 91430100740620301T

This company holds 170 NMPA certificates in China and has registrations in United States — 1 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
170China registrations
Class I 4Class II 162Class III 3
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union162 raw hits, 162 excluded, 0 confirmed
United States0 registration records, 1 510(k), 0 PMA, 4 excluded
China170 certificates (Class III 3 / II 162 / I 4), as of 2026-09-04
United Kingdom0 confirmed, 1 excluded
Brazil0 confirmed, 1 excluded

Regulatory identity

Unified social credit code
91430100740620301T
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
2,849
Annual revenue
over RMB 500M
Website
www.sinocare.com
Product categories
医用电子临床检验器械及试剂健康管理医用诊察和监护器械

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2002-08-07
Registered capital
CNY 556,845,806
Paid-in capital
CNY 556,845,893
Legal form
Joint-stock limited company (listed, natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-06-15
Recognitions
National High-Tech EnterpriseGazelle enterpriseAbove-designated-size industrial enterprise
Listing
Listed on the A-share market

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

12023 · K231476

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20243072511持续葡萄糖监测系统Class III
CN国械注准20243072505持续葡萄糖监测系统Class III
CN国械注准20233070435持续葡萄糖监测系统Class III
CN湘械注准20262400171乳酸试条(乳酸氧化酶法)Class II
USK231476TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System2023-12-01

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