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LDL Cholesterol

by Cypress Diagnostics

Ref HBL012

LDL Cholesterol (HBL012) is an in vitro diagnostic device (EU IVDD general IVD; EMDN category low density lipoprotein cholesterol including sd-ldl) made by Cypress Diagnostics, registered in EUDAMED on 19 Mar 2026 (Basic UDI-DI B-05404035101582), active as of 22 Oct 2026.

Active European Union

CE IVDD

Valid until

No date given

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

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05404035101582 Basic UDI-DI 05404035101582UDI-DIDate19 Mar 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / reference
HBL012
Primary DI / UDI-DI
05404035101582
Basic UDI-DI
B-05404035101582
EMDN code
W01010221 Low density lipoprotein cholesterol including sd-ldl
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000000033

From the manufacturer

Manufacturer's product page: Calculate the LDL-Cholesterol

Similar devices in this category

Other devices filed under LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL.

Other devices from Cypress Diagnostics

See all devices from Cypress Diagnostics →

Properties

  • Reagent
  • IVD kit
  • Professional testing
Other properties (9, all answered No)