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Guangzhou Decheng Biotechnology Co., Ltd.

China · Guangzhou

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia — 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

pendingnot queried

USUnited StatesFDA openFDA

35listed device types

Class I 4Class II 29Class III 0unclassified 2

plus 18 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

12registered devices

Class II 12

18 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

6 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IVD Class 2 1IVD Class 3 2

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.

United States18 registration records, 8 510(k), 0 PMA

Brazil12 confirmed, 0 excluded

Manufacturer names merged into this page: Guangzhou Decheng Biotechnology Co., Ltd. · GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD.

FDA 510(k) clearances by year

12022 · K222305

22023 · K232659

22024 · K240643

32025 · K251040

FDA listed device types

showing 8 of 35

Kit, Test, Pregnancy, Hcg, Over The Counter 1Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt 1Enzyme Immunoassay, Opiates 1Enzyme Immunoassay, Benzodiazepine 1Thin Layer Chromatography, Methamphetamine 1Test, Benzodiazepine, Over The Counter 1Test, Tricyclic Antidepressants, Over The Counter 1Test, Methadone, Employment And Insurance Testing, Exempt 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251040	MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test	2025-09-09
US	K250067	Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro	2025-02-20
US	K242428	Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus	2025-02-06
BR	82444370128	Kit de Teste Rápido Proteína C Reativa (hsPCR&PCR) (Teste Imunocromato	Class II
BR	82444370048	Teste Rápido de Gravidez Digital MissLan	Class II
BR	82444370049	Teste Rápido de Ovulação Digital MissLan	Class II

Guangzhou Decheng Biotechnology Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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