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Chromogenic ESBL LAB-AGAR™/ Chromogenic Orientation LAB-AGAR™
EUDAMEDClass A (EU MDR)
Ref PD 063
Identity
- Device Name
- Chromogenic ESBL LAB-AGAR™/ Chromogenic Orientation LAB-AGAR™ EUDAMED
- Model / Reference
- PD 063 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902643931381 EUDAMED
- Basic UDI-DI
- 59026439APD063DS EUDAMED
- EMDN Code
- W0104010402 CHROMOGENIC ID MEDIA (PLATES) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Chromogenic ESBL LAB-AGAR™/ Chromogenic Orientation LAB-AGAR™ by BioMaxima Spółka Akcyjna — Class A — 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 | 59026439APD063DS | Class A | Active |
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Manufacturer
- Manufacturer
- BioMaxima Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000039473
Sources (1)
- EUDAMED 96e6bd16-ba73-4370-8745-92de3b875908 61 fields · synced Jun 18, 2026