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MycoMDx Carbapenem resistance gene Assay (F-PCR)
EUDAMEDClass IVD General (EU MDR)
Ref DNK-1901-20Model 50 testsModel 24 testsModel 48 tests
Identity
- Device Name
- MycoMDx Carbapenem resistance gene Assay (F-PCR) EUDAMED
- Model / Reference
- 50 tests EUDAMEDDNK-1901-20 EUDAMED24 tests EUDAMED48 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930317801981 EUDAMED06930317888319 EUDAMED06930317892651 EUDAMED
- Basic UDI-DI
- B-06930317801981 EUDAMEDB-06930317888319 EUDAMEDB-06930317892651 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMEDW0104080606 NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMEDTürkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMEDEUDAMED
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 Carbapenem resistance gene Assay (F-PCR) 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-06930317801981 | 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 (3)
- EUDAMED 815ff9f1-1679-4b37-a986-53d2b1ceb660 61 fields · synced Oct 6, 2026
- EUDAMED d6bff60a-de3a-414c-88c0-f70f1b5f6853 61 fields · synced May 19, 2026
- EUDAMED c5ade397-6da0-488e-a38d-9231710f986d 61 fields · synced May 19, 2026