Identity
- Trade Name
- Phenyloalanine LAB-AGAR™ /skos/slant EUDAMED
- Device Name
- Phenylalanine LAB-AGAR™ /skos/slant EUDAMEDPhenylalanine LAB-AGAR™ EUDAMED
- Model / Reference
- PW 3119 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902643940857 EUDAMED
- Basic UDI-DI
- 59026439ATPHEP3 EUDAMED59026439ASPHENU EUDAMED
- EMDN Code
- W0104010206 MEDIA IN TUBES (SOLID & LIQUID) 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
Phenylalanine LAB-AGAR™ /skos/slant 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 | 59026439ATPHEP3 | Class A | Active |
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Manufacturer
- Manufacturer
- BioMaxima Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000039473
Sources (2)
- EUDAMED 06e7acb1-bf53-48ed-8590-d4d08aaf7ae3 61 fields · synced Jun 18, 2026
- EUDAMED 309c1750-e295-40e1-b82a-a34c21c6dea6 61 fields · synced Jun 18, 2026