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Mycobacterium Tuberculosis Isoniazid and Fluoroquinolone Resistance Gene Test K…
EUDAMEDClass IVD General (EU MDR)
Ref 10210102AModel 10 tests/kit
Identity
- Device Name
- Mycobacterium Tuberculosis Isoniazid and Fluoroquinolone Resistance Gene Test Kit (Fluorescent PCR Method) EUDAMED
- Model / Reference
- 10 tests/kit EUDAMED10210102A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974795550252 EUDAMED
- Basic UDI-DI
- B-06974795550252 EUDAMED
- EMDN Code
- W0105010799 MYCOBACTERIA REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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 Isoniazid and Fluoroquinolone Resistance Gene Test K… by RocGene (Xuzhou) Technology Limited — Class IVD General — IVDD — listed in…
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-06974795550252 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- RocGene (Xuzhou) Technology Limited
- EUDAMED SRN
- CN-MF-000024511
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED b1eeecf7-6468-4ce6-9f36-7462740c0c4b 61 fields · synced Jul 10, 2026