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Diagnostic Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence)
EUDAMEDClass IVD General (EU MDR)
Ref DA0050Model 20 tests/kitRef DA0052
Identity
- Device Name
- Diagnostic Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence) EUDAMED
- Model / Reference
- 20 tests/kit EUDAMEDDA0050 EUDAMEDDA0052 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928103000502 EUDAMED06928103000526 EUDAMED
- Basic UDI-DI
- B-06928103000502 EUDAMEDB-06928103000526 EUDAMED
- EMDN Code
- W0105010703 MYCOBACTERIAL DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Diagnostic Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence) by Daan Gene 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-06928103000502 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Daan Gene Co., Ltd.
- EUDAMED SRN
- CN-MF-000025799
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 3722ffe1-54f3-48bd-ad4c-8ff252ddfdf1 61 fields · synced Jul 20, 2026
- EUDAMED 2a6c9913-9fce-4275-b74e-f4d1f9ea4252 61 fields · synced May 18, 2026