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Columbia LAB-AGAR™ +5% KB / MacConkey LAB-AGAR™ / płytka dwudzielna
EUDAMEDClass A (EU MDR)
Ref PD 014Ref PD 053
Identity
- Trade Name
- MacConkey LAB-AGAR™ / MacConkey LAB-AGAR™ / płytka dwudzielna EUDAMED
- Device Name
- Columbia LAB-AGAR™ +5% KB / MacConkey LAB-AGAR™ / płytka dwudzielna EUDAMEDMacConkey LAB-AGAR™ EUDAMED
- Model / Reference
- PD 014 EUDAMEDPD 053 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902643930940 EUDAMED05902643931305 EUDAMED
- Basic UDI-DI
- 59026439APD014DD EUDAMED59026439ASMACCMC EUDAMED
- EMDN Code
- W0104010407 BI-PLATES - INCLUDING NON-CHROMOGENIC & CHROMOGENIC MEDIA COMBINATION EUDAMED
Classification
- Device Class
- Class A 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
Columbia LAB-AGAR™ +5% KB / MacConkey LAB-AGAR™ / płytka dwudzielna by BioMaxima Spółka Akcyjna — Class A — IVDR — listed in EUDAMED
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 | 59026439APD014DD | Class A | Active |
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Manufacturer
- Manufacturer
- BioMaxima Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000039473
Sources (2)
- EUDAMED 2d49097c-ce40-4cb2-a9f4-2b217172b83a 61 fields · synced Oct 5, 2026
- EUDAMED e530dde1-e680-42e0-8e84-0050eba411fd 61 fields · synced Jul 16, 2026