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Hemoglobin Calibrator

by Cypress Diagnostics

Ref HBS02

Hemoglobin Calibrator (HBS02) is an in vitro diagnostic device (EU IVDD general IVD; EMDN category calibrators single component (cc)) made by Cypress Diagnostics, registered in EUDAMED on 20 Mar 2026 (Basic UDI-DI B-05404035101629), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05404035101629 Basic UDI-DI 05404035101629UDI-DIDate20 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  • Withdrawn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
HBS02
Primary DI / UDI-DI
05404035101629
Basic UDI-DI
B-05404035101629
EMDN code
W0101050302 Calibrators single component (cc)
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

Similar devices in this category

Other devices filed under CALIBRATORS SINGLE COMPONENT (CC).

Other devices from Cypress Diagnostics

See all devices from Cypress Diagnostics →

Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
Other properties (8, all answered No)