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Clostridium difficile GDH+A+B kas. 20szt
EUDAMEDClass B (EU MDR)
Ref 1-327-K020
Identity
- Device Name
- Clostridium difficile GDH+A+B kas. 20szt EUDAMED
- Model / Reference
- 1-327-K020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902643958449 EUDAMED
- Basic UDI-DI
- 59026439BRT327JQ EUDAMED
- EMDN Code
- W0105090106 CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Clostridium difficile GDH+A+B kas. 20szt by BioMaxima Spółka Akcyjna — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 59026439BRT327JQ | Class B | Active |
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Manufacturer
- Manufacturer
- BioMaxima Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000039473
Sources (1)
- EUDAMED f8e28024-fc63-44f3-80d1-c13b48437347 61 fields · synced Jun 19, 2026