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PowerChek™ MTB/NTM Real-time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref IR0120
Identity
- Trade Name
- PowerChek™ MTB/NTM Real-time PCR Kit EUDAMED
- Device Name
- PowerChek™ MTB/NTM Real-time PCR Kit EUDAMED
- Model / Reference
- IR0120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800056301005 EUDAMED
- Basic UDI-DI
- B-08800056301005 EUDAMED
- EMDN Code
- W0105010703 MYCOBACTERIAL DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
PowerChek™ MTB/NTM Real-time PCR Kit by KogeneBiotech 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-08800056301005 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- KogeneBiotech Co., Ltd.
- EUDAMED SRN
- KR-MF-000045858
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED f00c0c53-b813-42d4-a863-ebb2c13fcccb 61 fields · synced Jun 19, 2026