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Home›China›Fosun Diagnostics (Shanghai) Co., Ltd

Fosun Diagnostics (Shanghai) Co., Ltd

China · Shanghai · www.fosundiagnostics.com/en/web/index.do
✓ Record-verifiedregistrations found in 2 marketsEU SRN CN-MF-000028169

This company has registrations in European Union, Hong Kong — 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
5UDI-DI device records
IVD general 2ivd-devices-self-testing 3
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
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
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
3valid listings
IVD C 3
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 Union31 raw hits, 26 excluded, 5 confirmed
Brazil0 confirmed, 3 excluded

Regulatory identity

EU manufacturer SRN
CN-MF-000028169
EU authorised representative
Obelis s.a.

Company information

Country
China
City
Shanghai
Website
www.fosundiagnostics.com/en/web/index.do
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
EU06931654312420Covid-19 Antigen CARD Kitivd-devices-self-testing
EU06931654312413Covid-19 Antigen CARD Kitivd-devices-self-testing
EU06931654312406Covid-19 Antigen CARD Kitivd-devices-self-testing
EU06931654310075Fosun 2019-nCoV qPCRIVD general

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