Apo A1

EUDAMED

Class IVD General (EU MDR)

Ref 1417-0550Ref 1415-0550

by Medicon Hellas SA

Identity

Trade Name: APO A1 EUDAMED
Device Name: APO A1 EUDAMED
Model / Reference: 1417-0550 EUDAMED
1415-0550 EUDAMED

Identifiers

Primary DI / UDI-DI: 05204309137114 EUDAMED
05204309168224 EUDAMED
Basic UDI-DI: B-05204309137114 EUDAMED
B-05204309168224 EUDAMED
EMDN Code: W0102010401 APOLIPOPROTEIN A I EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Greece EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

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-05204309137114	Class IVD General	Active

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Manufacturer

Manufacturer: Medicon Hellas SA
EUDAMED SRN: GR-MF-000013625

Sources (2)

EUDAMED a0dce61b-d1a7-423c-ac1c-a34b4db2a13c 61 fields · synced Jul 15, 2026
EUDAMED 2e734458-7dee-4fb9-9b7b-adc71aef3269 61 fields · synced May 18, 2026