Pure Global

Suzhou Hokapi Biomedical Engineering Co., Ltd.. - Manufacturer 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.

Free Manufacturer Profile
Powered by Pure Global AI
71 Devices
3 Risk Classes
Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer - China
71
Total Devices
3
Risk Classes
2021
Earliest Version
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Recent Products (Latest 10)
Most recently updated devices in the database
Device NameRisk ClassDetail
Automatic Blood Grouping Analyzer
Class A
HOKAPI™ AE-200
Class A
HOKAPI™ NSE
IVD General
HOKAPI™ SARS-CoV-2 IgM
IVD General
HOKAPI™ SARS-COV-2 NEUTRALIZING AB
IVD General
HOKAPI™ SARS-CoV-2 IgG
IVD General
HOKAPI™ TSH
IVD General
HOKAPI™ LH
IVD General
HOKAPI™ FSH
IVD General
HOKAPI™ ANTI-TPO
IVD General
Risk Class Distribution
Breakdown by risk classification
IVD General
66(93.0%)
Class A
3(4.2%)
IVD Annex II List B
2(2.8%)
Top Authorized Representatives
Most common authorized representatives for this manufacturer
Authorized RepresentativeDevice CountPercentageView
Shanghai International Holding Corp. GmbH(Europe)
71100.0%