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Manufacturer profile

Dynamiker Biotechnology (Tianjin) Co., Ltd.

EU EUDAMEDChina191 registered devices
VerifiedEUDAMED · official EU database
191
Total devices
2
Risk classes
2022
Earliest version
2023
Latest version
Regulatory footprint
Search Dynamiker Biotechnology (Tianjin) Co., Ltd. across other regulatory registries
ThailandColombiaVietnamSouth KoreaEcuadorUnited States
Recent products (latest 10)
Most recently updated devices in the database
Dynamiker Influenza A Antigen Assay (POCT Chemiluminescence)
06930317807747
IVD General
Dynamiker Candida albicans IgG Assay (POCT Chemiluminescence)
06930317819153
IVD General
Dynamiker Aspergillus fumigatus IgG Assay (POCT Chemiluminescence)
06930317826205
IVD General
Dynamiker Candida Mannan Assay (POCT Chemiluminescence)
06930317829961
IVD General
Dynamiker Fungus (1-3)-β-D-Glucan Assay (POCT Chemiluminescence)
06930317830684
IVD General
Dynamiker Candida albicans IgG Assay (POCT Chemiluminescence)
06930317842236
IVD General
Dynamiker Cryptococcus neoformans Antigen Assay (POCT Chemiluminescence)
06930317865518
IVD General
Dynamiker Fungus (1-3)-β-D-Glucan Assay (POCT Chemiluminescence)
06930317866553
IVD General
Dynamiker Influenza A Antigen Assay (POCT Chemiluminescence)
06930317870048
IVD General
Dynamiker Candida Mannan Assay (POCT Chemiluminescence)
06930317805873
IVD General
Risk class distribution
Breakdown by risk classification
IVD General18999.0% of total
IVD devices for self-testing21.0% of total
Top authorized representatives
Most common authorized representatives for this manufacturer
Lotus NL B.V.
99.0%189 devices
PureCE B.V.
1.0%2 devices
About this profile

Explore comprehensive manufacturer profile for Dynamiker Biotechnology (Tianjin) Co., Ltd. through Pure Global AI's free EU medical device database. This company manufactures 191 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: 189, IVD devices for self-testing: 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.