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Mycobacterium Tuberculosis and Drug-resistant Gene Nucleic Acid Testing Kit(PCR…
EUDAMEDClass IVD General (EU MDR)
Ref TB002-48
Identity
- Trade Name
- Mycobacterium Tuberculosis and Drug-resistant Gene Nucleic Acid Testing Kit(PCR Fluorescent Probe Method) EUDAMED
- Device Name
- Mycobacterium Tuberculosis and Drug-resistant Gene Nucleic Acid Testing Kit(PCR Fluorescent Probe Method) EUDAMED
- Model / Reference
- TB002-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974081870415 EUDAMED
- Basic UDI-DI
- B-06974081870415 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 and Drug-resistant Gene Nucleic Acid Testing Kit(PCR… by Singuway Biotech Inc. — 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-06974081870415 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Singuway Biotech Inc.
- EUDAMED SRN
- CN-MF-000027180
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 303b4364-486d-43e5-883a-5f61dd201fb9 61 fields · synced Jun 17, 2026