HomeChinaHangzhou Bigfish Bio-tech Co., Ltd.

Hangzhou Bigfish Bio-tech Co., Ltd.

China · Hangzhou Zhejiang · www.bigfishgene.com
✓ Record-verifiedregistrations found in 2 marketsEU SRN CN-MF-000027212

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
99UDI-DI device records
Class I 4IVD A 95
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
3registered devices
Class I 3
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
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 Union99 raw hits, 0 excluded, 99 confirmed
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: HANGZHOU BIGFISH BIO-TECH CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000027212
EU authorised representative
SUNGO Europe B.V.

Company information

Country
China
City
Hangzhou Zhejiang
Website
www.bigfishgene.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsMolecular diagnostics & genomicsPCR & qPCR

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
EU06975514361050IVD A
EU06975514361043IVD A
EU06975514360121IVD A
EU06975514360114IVD A
BR80680420039Robô de Purificação de ácido nucleico Spirall BFEXClass I
BR80861970041Instrumento Automático de Purificação de Ácido Nucleico - DPSClass I
BR80861970042Kit de Purificação e Extração de Ácidos Nucleicos MagaPure DPSClass I

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