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Mycobacterium Tuberculosis (TB) Real Time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref RD-1060-02Ref RD-0060-02
Identity
- Trade Name
- Mycobacterium Tuberculosis (TB) Real Time PCR Kit EUDAMED
- Device Name
- Mycobacterium Tuberculosis (TB) Real Time PCR Kit EUDAMED
- Model / Reference
- RD-1060-02 EUDAMEDRD-0060-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971042229664 EUDAMED06971042227646 EUDAMED
- Basic UDI-DI
- B-06971042229664 EUDAMEDB-06971042227646 EUDAMED
- EMDN Code
- W0105010703 MYCOBACTERIAL DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
Mycobacterium Tuberculosis (TB) Real Time PCR Kit by Shanghai Zj Bio-Tech 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-06971042229664 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shanghai Zj Bio-Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000017861
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 42926fb9-c9d1-4f7c-b74f-6d6a929570a4 61 fields · synced Sep 18, 2026
- EUDAMED 3fac0fc5-b8e8-4ca8-8167-477b75c4af36 61 fields · synced May 18, 2026