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HANGZHOU BIOTEST BIOTECH CO., LTD.

China · Hangzhou

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 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

41listed device types

Class I 3Class II 34Class III 0unclassified 4

plus 25 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

19registered devices

Class II 19

88 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

6active device licences

Class II 6

16 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

7device registrations

CLASS B 7

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IVD Class 2 1IVD Class 3 2

HKHong KongMDACS

2valid listings

IVD B 1IVD C 1

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

13active registrations

Class 2a 2Class 2b 8Class 3 3

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 States25 registration records, 0 510(k), 0 PMA, 5 excluded

Brazil19 confirmed, 0 excluded

Canada6 confirmed, 1 excluded

Manufacturer names merged into this page: Hangzhou Biotest Biotech Co.,Ltd. · HANGZHOU BIOTEST BIOTECH CO., LTD. · HANGZHOU BIOTEST BIOTECH CO., LTD · HANGZHOU BIOTEST BIOTECH CO. LTD. · HANGZHOU BIOTEST BIOTECH CO., LTD,

FDA listed device types

showing 8 of 41

Test, Follicle Stimulating Hormone (Fsh), Over The Counter 1Test, Luteinizing Hormone (Lh), Over The Counter 1Enzyme Immunoassay, Nicotine And Nicotine Metabolites 1Kit, Test, Pregnancy, Hcg, Over The Counter 1Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt 1Enzyme Immunoassay, Opiates 1Enzyme Immunoassay, Benzodiazepine 1Test, Propoxyphene, Over The Counter 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80560310079	MedTeste Calprotectina (Teste Rápido)	Class II
BR	80560310081	MedTeste RSV (Teste Rápido)	Class II
BR	80560310072	MedTeste Rotavírus (Teste Rápido)	Class II
CA	93758	HCG PREGNANCY RAPID TEST STRIP(URINE)	Class II
CA	93759	LH OVULATION RAPID TEST STRIP(URINE)	Class II
CA	93828	HCG PREGNANCY RAPID TEST CASSETTE(URINE)	Class II

HANGZHOU BIOTEST BIOTECH CO., LTD.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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