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MycoMDx Mycobacterium tuberculosis complex nucleic acid test kit (F-PCR)
EUDAMEDClass IVD General (EU MDR)
Ref DNK-1901-21Model 50 testsModel 20 tests
Identity
- Device Name
- MycoMDx Mycobacterium tuberculosis complex nucleic acid test kit (F-PCR) EUDAMED
- Model / Reference
- 50 tests EUDAMEDDNK-1901-21 EUDAMED20 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930317804326 EUDAMED06930317804333 EUDAMED
- Basic UDI-DI
- B-06930317804326 EUDAMEDB-06930317804333 EUDAMED
- EMDN Code
- W0105010703 MYCOBACTERIAL DETECTION BY NA REAGENTS 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
Yes
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
MycoMDx Mycobacterium tuberculosis complex nucleic acid test kit (F-PCR) by Dynamiker Biotechnology (Tianjin) Co., Ltd. — Class IVD General — IVDD — listed in…
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-06930317804326 | 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 26f9cfe9-8e64-4f40-9e0d-d62588ad7922 61 fields · synced Jul 21, 2026
- EUDAMED 405a6e69-51d4-4d24-b7c7-f3c05cbd52f7 61 fields · synced May 16, 2026