Pure Global

Hangzhou Alltest Biotech.Co.,Ltd. - Manufacturer Profile

Explore comprehensive manufacturer profile for Hangzhou Alltest Biotech.Co.,Ltd. through Pure Global AI's free EU medical device database. This company manufactures 169 medical devices registered with EUDAMED across 7 risk classes based in China.

This page provides detailed insights including recent registrations, risk class distribution (IVD Annex II List B: 1, IVD devices for self-testing: 57, Class A: 37, Class B: 24, Class C: 12, ...), 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
169 Devices
7 Risk Classes
Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer - China
169
Total Devices
7
Risk Classes
2022
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
H. pylori Antibody Rapid Test
Class B
H. pylori Antibody Rapid Test
Class B
Syphilis Rapid Test
Class C
H. pylori Antibody Rapid Test
Class B
Rotavirus and Adenovirus Combo Rapid Test
Class B
Rotavirus and Adenovirus Combo Rapid Test
Class B
H. pylori Antibody Rapid Test
Class B
H.pylori Antigen Rapid Test Cassette
IVD devices for self-testing
Dengue NS1 Rapid Test
Class C
Dengue Combo Rapid Test Cassette
IVD General
Risk Class Distribution
Breakdown by risk classification
IVD devices for self-testing
57(33.7%)
Class A
37(21.9%)
IVD General
33(19.5%)
Class B
24(14.2%)
Class C
12(7.1%)
IVD Annex II List A
5(3.0%)
IVD Annex II List B
1(0.6%)
Top Authorized Representatives
Most common authorized representatives for this manufacturer
Authorized RepresentativeDevice CountPercentageView
MedNet EC-REP GmbH
16899.4%
Lotus NL B.V.
10.6%