Identity
- Trade Name
- APO A1/B CONTROL LEV2 EUDAMED
- Device Name
- APO A1/B CONTROL LEV2 EUDAMED
- Model / Reference
- 1578-0554 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309120994 EUDAMED
- Basic UDI-DI
- B-05204309120994 EUDAMED
- EMDN Code
- W0102152003 SPECIFIC PROTEIN CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Apo A1/B Control Lev2 by Medicon Hellas SA — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05204309120994 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (1)
- EUDAMED a9d59227-38e1-4f94-b7d6-f19d78038520 61 fields · synced Jun 20, 2026