Identity
- Trade Name
- PaxView TB/NTM MPCR-ULFA Kit EUDAMED
- Device Name
- PaxView TB/NTM MPCR-ULFA Kit EUDAMED
- Model / Reference
- V0401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800097500009 EUDAMED
- Basic UDI-DI
- B-08800097500009 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
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
PaxView TB/NTM MPCR-ULFA Kit by PaxGenBio 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-08800097500009 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- PaxGenBio Co., Ltd.
- EUDAMED SRN
- KR-MF-000024696
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 9c84d674-1af7-4822-84c9-9c1f03b17a9e 61 fields · synced Jun 19, 2026