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Dynamiker Fungal Nucleic Acid Extraction Kit
EUDAMEDClass IVD General (EU MDR)
Ref DNK-1901-23Model 50 testsModel 250 tests
Identity
- Device Name
- Dynamiker Fungal Nucleic Acid Extraction Kit EUDAMED
- Model / Reference
- 50 tests EUDAMEDDNK-1901-23 EUDAMED250 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930317802063 EUDAMED06930317802087 EUDAMED
- Basic UDI-DI
- B-06930317802063 EUDAMEDB-06930317802087 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Dynamiker Fungal Nucleic Acid Extraction Kit by Dynamiker Biotechnology (Tianjin) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06930317802063 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
- EUDAMED SRN
- CN-MF-000001133
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED bbe26f58-c9f0-4802-b457-bce151467efe 61 fields · synced Jul 23, 2026
- EUDAMED a0f507e0-083b-4bf4-9817-409494ff6b52 61 fields · synced May 18, 2026