EUDAMED device

Lp(a) Calibrators

EUDAMED device 00380740157432 · Biokit S.A.

Key facts

Primary DI 00380740157432
Trade name Lp(a) Calibrators
Device name Quantia Lp(a)
Reference or catalog number 5P83-02
Manufacturer Biokit S.A.
Manufacturer SRN ES-MF-000002406
Risk class Class B
EMDN code W0102010405
EMDN description LIPOPROTEIN ( A )
Legislation ivdr
Implantable No
Sterile No
Single use No
Status date Oct 8, 2025

At a glance

  • Yes Matching FDA GUDID record

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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