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MycoMDx Candida PCR Assay
EUDAMEDClass IVD General (EU MDR)
Ref DNK-1417-1Model 48 testsModel 50 tests
Identity
- Device Name
- MycoMDx Candida PCR Assay EUDAMED
- Model / Reference
- 48 tests EUDAMEDDNK-1417-1 EUDAMED50 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930317896543 EUDAMED06930317801905 EUDAMED
- Basic UDI-DI
- B-06930317896543 EUDAMEDB-06930317801905 EUDAMED
- EMDN Code
- W0105060402 CANDIDA ALBICANS - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye EUDAMEDGreece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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 Candida PCR Assay by Dynamiker Biotechnology (Tianjin) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06930317896543 | 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 7ac923c0-da3d-41e9-99c3-0dec936e823f 61 fields · synced Jul 28, 2026
- EUDAMED ae8c322e-10e0-4530-884a-4b8572d6433d 61 fields · synced May 19, 2026