Identity
- Trade Name
- APO A1 EUDAMED
- Device Name
- APO A1 EUDAMED
- Model / Reference
- 1418-0557 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309070992 EUDAMED
- Basic UDI-DI
- B-05204309070992 EUDAMED
- EMDN Code
- W0102010401 APOLIPOPROTEIN A I EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Category: Apolipoprotein A-I (Apo A1) IVD, reagent
Apo A1 by Medicon Hellas SA — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Apolipoprotein A-I (Apo A1) IVD, reagent.
- APOLIPOPROTEÍNA A1 — QUIMICA CLINICA APLICADA S.A. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Nephstar Apo A1 Kit — Goldsite Diagnostics Inc. · IVD General
- Apolipoprotein AⅠ (ApoAⅠ) — Maccura Biotechnology Co., Ltd. · IVD General
- Apolipoprotein A1 — Diagam S.A. · IVD General
- Apolipoprotein AⅠ (ApoAⅠ) — Maccura Biotechnology Co., Ltd. · IVD General
- Apolipoprotein A1 Reagent Kit — HANGZHOU AICHEK MEDICAL TECHNOLOGY CO., LTD. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
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-05204309070992 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (1)
- EUDAMED 0e85ddd5-ccd0-4be7-a265-1c428d665240 61 fields · synced Jun 18, 2026