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Home›China›Shanghai Kehua Bio-engineering Co., Ltd.

Shanghai Kehua Bio-engineering Co., Ltd.

China · Shanghai · www.skhb.com
✓ Record-verifiedregistrations found in 2 marketsEU SRN CN-MF-000017428

This company has registrations in European Union, 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
pendingnot queried
EUEuropean UnionEUDAMED
152UDI-DI device records
IVD A 30IVD general 122
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
0registered devices
2 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.

European Union235 raw hits, 83 excluded, 152 confirmed
United States0 registration records, 0 510(k), 0 PMA, 2 excluded
Brazil0 confirmed, 1 excluded
Manufacturer names merged into this page: SHANGHAI KEHUA BIO-ENGINEERING CO., LTD (KHB) · SHANGHAI KEHUA BIO-ENGINEERING CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000017428
EU authorised representative
Obelis s.a.

Company information

Country
China
City
Shanghai
Website
www.skhb.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsClinical chemistry & immunoassays

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.

Registration details (sample)

MarketIdentifierNameClass / date
EU06974847813021ST-36WF Microplate WasherIVD A
EU06974847813014ST-36WT Microplate WasherIVD A
EU06974847813045ST-98W Microplate WasherIVD A
EU06974847812536ST-980 Microplate ReaderIVD A

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