Apolipoprotein A1

EUDAMED

Class IVD General (EU MDR)

Ref AATUR-H00/UDA

by Diagam S.A.

Identity

Trade Name: Apolipoprotein A1 EUDAMED
Device Name: Apolipoprotein A1 EUDAMED
Model / Reference: AATUR-H00/UDA EUDAMED

Identifiers

Primary DI / UDI-DI: 05415168016131 EUDAMED
Basic UDI-DI: B-05415168016131 EUDAMED
EMDN Code: W0102010401 APOLIPOPROTEIN A I EUDAMED

Classification

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

Apolipoprotein A1 by Diagam S.A. — 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
APO A1 — Medicon Hellas SA · IVD General
Apolipoprotein AⅠ (ApoAⅠ) — Maccura Biotechnology Co., Ltd. · 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-05415168016131	Class IVD General	Active

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Manufacturer

Manufacturer: Diagam S.A.
EUDAMED SRN: BE-MF-000022993

Sources (1)

EUDAMED cd37d1a4-8bf7-40de-a545-173cd96aba8d 61 fields · synced Jun 18, 2026