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Galaxy MTB/RIF Assay
EUDAMEDClass IVD General (EU MDR)
Ref 106-0056-01Model 12 reactions/kit
Identity
- Trade Name
- Galaxy MTB/RIF Assay EUDAMED
- Device Name
- Diagnostic Kit for Mycobacterium Tuberculosis(MTB) complex DNA and Rifampicin resistance Mycobacterium tuberculosis(PCR-Fluorescence) EUDAMED
- Model / Reference
- 12 reactions/kit EUDAMED106-0056-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975447582119 EUDAMED
- Basic UDI-DI
- B-06975447582119 EUDAMED
- EMDN Code
- W0105010703 MYCOBACTERIAL DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Galaxy MTB/RIF Assay by Igenesis(Shanghai)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-06975447582119 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Igenesis(Shanghai)Co., Ltd.
- EUDAMED SRN
- CN-MF-000001552
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED f7e6597f-d33a-4e9d-b8f6-c4d4ffb75a3a 61 fields · synced Jun 19, 2026