LP(a)

EUDAMED

Class IVD General (EU MDR)

Ref 1419-0530Ref 1415-0530

by Medicon Hellas SA

Identity

Trade Name: LP(a) EUDAMED
Device Name: LP(a) EUDAMED
Model / Reference: 1419-0530 EUDAMED
1415-0530 EUDAMED

Identifiers

Primary DI / UDI-DI: 05204309123049 EUDAMED
05204309168217 EUDAMED
Basic UDI-DI: B-05204309123049 EUDAMED
B-05204309168217 EUDAMED
EMDN Code: W0102010405 LIPOPROTEIN ( A ) 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 B (Apo B) IVD, reagent

LP(a) by Medicon Hellas SA — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Apolipoprotein B (Apo B) IVD, reagent.

BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
Lipoprotein (a) — Diagam S.A. · IVD General
Adenosine Deaminase Assay Kit (Peroxidase Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
Apolipoprotein B Reagent (ApoB 2 x 100) — Beckman Coulter, Inc. · IVD General
Apolipoprotein B Assay Kit (Immunoturbidimetric Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
Lipoprotein (a) Kit (Latex-Enhanced Immunoturbidimetric Method) — MEDICALSYSTEM BIOTECHNOLOGY CO., LTD. · IVD General
Apolipoprotein B Assay Kit (Immunoturbidimetric Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
Adenosine Deaminase Assay Kit (Peroxidase Method) — Da Te Bioengineering Technology Co., LTD. · IVD General

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-05204309123049	Class IVD General	Active

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Manufacturer

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

Sources (2)

EUDAMED e7715be1-0140-4679-abd8-eb48c15bc4f2 61 fields · synced Jul 25, 2026
EUDAMED e5616799-c873-429f-9983-8a09501f9633 61 fields · synced May 18, 2026