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MycoMDx Mucor PCR Assay
EUDAMEDClass IVD General (EU MDR)
Ref DNK-2108-1Model 48 testsModel 50 tests
Identity
- Device Name
- MycoMDx Mucor PCR Assay EUDAMED
- Model / Reference
- 48 tests EUDAMEDDNK-2108-1 EUDAMED50 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930317818187 EUDAMED06930317801936 EUDAMED
- Basic UDI-DI
- B-06930317818187 EUDAMEDB-06930317801936 EUDAMED
- EMDN Code
- W0105060499 MYCOLOGY NA REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye EUDAMEDItaly 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 Mucor 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-06930317818187 | 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 83a0a17d-5347-4182-9fe6-b95863888b0f 61 fields · synced Oct 6, 2026
- EUDAMED fa2a7dc2-ed27-4d5b-963c-e9118eb99445 61 fields · synced May 19, 2026