HomeChinaW.H.P.M. Bioresearch&Technology Co., Ltd

W.H.P.M. Bioresearch&Technology Co., Ltd

China · Beijing · www.whpm.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000003007

This company has registrations in European Union, United States, Canada, South Korea, Israel, Russia — 6 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
58UDI-DI device records
IVD general 7ivd-devices-self-testing 51
USUnited StatesFDA openFDA
37listed device types
Class I 3Class II 33Class III 0unclassified 1
plus 26 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
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
1active device licences
Class II 1
10 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
IVD import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
2active registrations
Class 2a 2
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 Union104 raw hits, 46 excluded, 58 confirmed
United States26 registration records, 0 510(k), 0 PMA, 10 excluded
United Kingdom0 confirmed, 1 excluded
Brazil0 confirmed, 1 excluded
Canada1 confirmed, 2 excluded
Manufacturer names merged into this page: W.H.P.M. Bioresearch & Technology Co., Ltd. · W.H.P.M. BIORESEARCH & TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000003007
EU authorised representative
MDSS GmbH

Company information

Country
China
City
Beijing
Website
www.whpm.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsMolecular diagnostics & genomicsCompanion diagnostics

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 listed device types

showing 8 of 37
Test, Follicle Stimulating Hormone (Fsh), Over The Counter 1Fluorometer, For Clinical Use 1Test, Luteinizing Hormone (Lh), Over The Counter 1Kit, 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 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06909620251233Telano drug test (COC strip)ivd-devices-self-testing
EU06909620251226Telano drug test (COC strip)ivd-devices-self-testing
EU06909620251141Telano Ovulation Testivd-devices-self-testing
EU06909620251134Telano Ovulation Testivd-devices-self-testing
CA95736VERITEST TEST DE GROSSESSE EN UNE ETAPEClass II

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