Identity
- Trade Name
- Chromogenic E. coli 0157 LAB-AGAR™ EUDAMED
- Device Name
- Chromogenic E.coli O157 LAB-AGAR™ EUDAMED
- Model / Reference
- PS 589- 100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902643914773 EUDAMED
- Basic UDI-DI
- 59026439ABCHECEL EUDAMED
- EMDN Code
- W0104010101 DEHYDRATED CULTURE MEDIA (DCM) 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
Chromogenic E. coli 0157 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 | 59026439ABCHECEL | Class A | Active |
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Manufacturer
- Manufacturer
- BioMaxima Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000039473
Sources (1)
- EUDAMED b19c2b28-7537-45ea-b5b9-264b7bc98186 61 fields · synced Jul 29, 2026