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Manufacturer profile

Suzhou Hokapi Biomedical Engineering Co., Ltd..

EU EUDAMEDChina71 registered devices
VerifiedEUDAMED · official EU database
71
Total devices
3
Risk classes
2021
Earliest version
2022
Latest version
Regulatory footprint
Search Suzhou Hokapi Biomedical Engineering Co., Ltd.. across other regulatory registries
ThailandColombiaSouth KoreaCanadaEcuadorSaudi Arabia
Recent products (latest 10)
Most recently updated devices in the database
Automatic Blood Grouping Analyzer
06939716400283
Class A
HOKAPI™ AE-200
06939716402430
Class A
HOKAPI™ NSE
06971390439685
IVD General
HOKAPI™ SARS-CoV-2 IgM
06971390439999
IVD General
HOKAPI™ SARS-COV-2 NEUTRALIZING AB
06939716400177
IVD General
HOKAPI™ SARS-CoV-2 IgG
06971390439975
IVD General
HOKAPI™ TSH
06971390434864
IVD General
HOKAPI™ LH
06971390434918
IVD General
HOKAPI™ FSH
06971390434895
IVD General
HOKAPI™ ANTI-TPO
06971390434888
IVD General
Risk class distribution
Breakdown by risk classification
IVD General6693.0% of total
Class A34.2% of total
IVD Annex II List B22.8% of total
Top authorized representatives
Most common authorized representatives for this manufacturer
Shanghai International Holding Corp. GmbH(Europe)
100.0%71 devices
About this profile

Explore comprehensive manufacturer profile for Suzhou Hokapi Biomedical Engineering Co., Ltd.. through Pure Global AI's free EU medical device database. This company manufactures 71 medical devices registered with EUDAMED across 3 risk classes based in China.

This page provides detailed insights including recent registrations, risk class distribution (IVD General: 66, Class A: 3, IVD Annex II List B: 2), and complete regulatory information from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry.