HomeSHENZHEN J&H BIOTECHNOLOGY CO., LTD

SHENZHEN J&H BIOTECHNOLOGY CO., LTD

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
26listed device types
Class I 26Class II 0Class III 0
plus 23 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
135registered devices
Class I 61Class II 74
136 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
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.

United States23 registration records, 5 510(k), 0 PMA, 125 excluded
Brazil135 confirmed, 67 excluded
Saudi Arabia0 confirmed, 3 excluded
Canada0 confirmed, 12 excluded
Manufacturer names merged into this page: Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd. · SHENZHEN DARTMON BIOTECHNOLOGY CO., LTD. · PNDUS BIOTECHNOLOGY (Shenzhen) Company, Ltd · SHENZHEN DYMIND BIOTECHNOLOGY CO., LTD · SHENZHEN GUSROM BIOTECHNOLOGY CO., LTD. · SHENZHEN J&H BIOTECHNOLOGY CO., LTD

Company information

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.

FDA 510(k) clearances by year

12018 · K182530
22019 · K192515
12020 · K193480
12023 · K230238

FDA listed device types

showing 8 of 26
Immunohistochemistry Reagents And Kits 1Fentanyl And Other Opioid Protection Glove 1First Aid Kit Without Drug 1Kit, Serological, Negative Control 1Slide Stainer, Automated 1Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus 1Personal Protection Kit 1Reagents, Specific, Analyte 1

Registration details (sample)

MarketIdentifierNameClass / date
USK230238BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx2023-03-31
USK193480BIOEASY Multi-Drug Test Cup2020-01-31
USK192515BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 202019-10-11
BR82444370207Analisador Automático de Hematologia DH-800[T7]CSClass II
BR82444370208Analisador Automático de Hematologia D7-CRPClass II
BR82444370348Família Analisadores Automáticos de Hematologia DH-80Class II

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