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Goldsite Diagnostics Inc.

China · Shenzhen Guangdong · www.goldsite.com.cn

✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000001353

This company has registrations in European Union, Brazil, South Korea, Israel, Russia — 5 overseas markets. 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

299UDI-DI device records

IVD A 18IVD general 281

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

15registered devices

Class I 4Class II 11

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

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

7active registrations

Class 2a 7

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 Union299 raw hits, 0 excluded, 299 confirmed

Brazil15 confirmed, 0 excluded

Manufacturer names merged into this page: GOLDSITE DIAGNOSTICS INC · GOLDSITE DIAGNOSTICS INC.

Regulatory identity

EU manufacturer SRN: CN-MF-000001353
EU authorised representative: CMC Medical Devices & Drugs SL

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06977125152447	HbA2 & HbF & HbA1c Calibrator	IVD general
EU	06977125152430	HbA2 & HbF & HbA1c Control	IVD general
EU	06977125152423	HbA2 & HbF & HbA1c Control	IVD general
EU	06977125152416	HbA2 & HbF & HbA1c Assay Kit (HPLC)	IVD general
BR	81652910106	GSH-60 Automatic HPLC HbA1c Analyzer	Class II
BR	81652910107	Família Calibradores e Controles de HbA1c GSH-60	Class II
BR	81652910108	Hemolise GSH-60	Class I

Goldsite Diagnostics Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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