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Changsha Sinocare Inc.

China · Changsha Hunan · www.sinocare.com

✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000012244

This company has registrations in European Union, United States, United Kingdom, Brazil, Singapore, South Korea, Australia, Hong Kong, Russia — 9 overseas markets. EU UDI-DI records ≥10, the first 300 verified individually. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

≥10UDI-DI device records

IVD C 10

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

2listed device types

Class I 1Class II 1Class III 0

plus 3 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

40registered device records

Class I 1Class IIb 4IVD general 4Class B – Self-testing or Near-patient Testing 2Class C – Self-testing or Near-patient Testing 10IVD Annex II List B 17IVD Devices for Self-Testing 2

BRBrazilANVISA

18registered devices

Class I 2Class II 16

27 including historic records

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

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Business type not stated 1Import 1

AUAustraliaTGA ARTG

3active ARTG entries

IVD Class 3 2IIb 1

HKHong KongMDACS

2valid listings

Class III 1IVD C 1

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

5active registrations

Class 2a 2Class 2b 2Class 3 1

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 Union1,214 raw hits, 290 excluded, 10 confirmed. Large result set — only the first 300 verified

United States3 registration records, 1 510(k), 0 PMA, 3 excluded

United Kingdom40 confirmed, 3 excluded

Brazil18 confirmed, 0 excluded

Manufacturer names merged into this page: Changsha Sinocare Inc. · CHANGSHA SINOCARE INC.

Regulatory identity

EU manufacturer SRN: CN-MF-000012244
EU authorised representative: SUNGO Europe B.V.
UK responsible person: SUNGO Certification Company Limited

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06934175049509	Sinocare	IVD C
EU	06934175049493	Sinocare	IVD C
EU	06934175044252	FHhub	IVD C
EU	06934175051700	Sinocare	IVD C
UK	44699	Creatinine Control Solution	Class B – Self-testing or Near-patient Testing
UK	53252	Creatinine Test Strip	Class B – Self-testing or Near-patient Testing
UK	64382	AffirmNow Creatinine Analyzer	IVD general
US	K170264	Gold AQ Blood Glucose Monitoring System	2017-10-05
BR	81464759049	Lanceta de Segurança Descartável Soft	Class II
BR	81464750171	Dispositivo Lancetador	Class I
BR	82832860087	C-Reactive Protein Quantitative Test Kit	Class II

Changsha Sinocare Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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