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Manufacturer profile

Shanghai BioGerm Medical Technology Co., Ltd.

EU EUDAMEDChina2 registered devices
VerifiedEUDAMED · official EU database
2
Total devices
2
Risk classes
2023
Earliest version
2023
Latest version
Regulatory footprint
Search Shanghai BioGerm Medical Technology Co., Ltd. across other regulatory registries
ThailandColombiaVietnamSouth KoreaEcuadorUnited States
Recent products (latest 2)
Most recently updated devices in the database
Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescent RT-MIRA)
06974677690298
IVD General
Automatic Nucleic Acid Purification Instrument
06974677691158
Class A
Risk class distribution
Breakdown by risk classification
IVD General150.0% of total
Class A150.0% of total
Top authorized representatives
Most common authorized representatives for this manufacturer
PureCE B.V.
50.0%1 devices
PureMDR GmbH
50.0%1 devices
About this profile

Explore comprehensive manufacturer profile for Shanghai BioGerm Medical Technology Co., Ltd. through Pure Global AI's free EU medical device database. This company manufactures 2 medical devices registered with EUDAMED across 2 risk classes based in China.

This page provides detailed insights including recent registrations, risk class distribution (IVD General: 1, Class A: 1), 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.