LP(a)

by Medicon Hellas SA 5 variants

Ref 1415-0530

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-05204309168217 Basic UDI-DI 05204309168217UDI-DI	Date13 Dec 2023Registered	StatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference: 1415-0530

Primary DI / UDI-DI: 05204309168217
Basic UDI-DI: B-05204309168217
EMDN Code: W0102010405 Lipoprotein ( a )

Device Class: Class IVD General
EU market of registration: Greece

Manufacturer details

EUDAMED SRN: GR-MF-000013625

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Properties

Animal Tissues
Reagent
Professional Testing

Other properties (7)

Sterile: No
Human Tissues: No
Microbial Substances: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No