Manufacturer profile
Qingdao Hightop Biotech Co., Ltd.
EU EUDAMED·China·14 registered devices
14
Total devices
3
Risk classes
2024
Earliest version
2025
Latest version
Recent products (latest 10)
Most recently updated devices in the database
FOB Fecal Occult Blood Rapid Test
06935091672024
IVD GeneralView
Strep A Antigen Rapid Test (Immunochromatography)
06935091672017
IVD GeneralView
IVD Annex II List BView
IVD Annex II List BView
IVD Annex II List BView
IVD Annex II List BView
IVD Annex II List BView
IVD Annex II List BView
IVD Annex II List BView
IVD Annex II List BView
Risk class distribution
Breakdown by risk classification
IVD Annex II List B
8(57.1%)
IVD General
4(28.6%)
IVD devices for self-testing
2(14.3%)
Top authorized representatives
Most common authorized representatives for this manufacturer
About this profile
Explore comprehensive manufacturer profile for Qingdao Hightop Biotech Co., Ltd. through Pure Global AI's free EU medical device database. This company manufactures 14 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: 4, IVD devices for self-testing: 2, IVD Annex II List B: 8), 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.