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Omlipo Apo A1 Kit

EUDAMED

Class IVD General (EU MDR)

Ref OP41050

by Goldsite Diagnostics Inc.

Identity

Trade Name: Omlipo Apo A1 Kit EUDAMED
Device Name: Omlipo Apo A1 Kit EUDAMED
Model / Reference: OP41050 EUDAMED

Identifiers

Primary DI / UDI-DI: 06971225930769 EUDAMED
Basic UDI-DI: B-06971225930769 EUDAMED
EMDN Code: W0102010401 APOLIPOPROTEIN A I EUDAMED

Classification

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

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

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

Omlipo Apo A1 Kit by Goldsite Diagnostics Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Apolipoprotein A-I (Apo A1) IVD, reagent.

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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

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Manufacturer

Manufacturer: Goldsite Diagnostics Inc.
EUDAMED SRN: CN-MF-000001353
Authorised Representative: CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (1)

EUDAMED 35489c0a-ff3e-448d-af7d-ab860ad10834 61 fields · synced Jun 18, 2026