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Glucose

by Cypress Diagnostics

Ref HBL04M, HBL04Model HBL04(A,M)

Glucose (HBL04M) is an in vitro diagnostic device (EU IVDR Class B; EMDN category glucose) made by Cypress Diagnostics, registered in EUDAMED on 29 Apr 2024 (Basic UDI-DI 54040351HBL046P), active as of 22 Oct 2026.

Active European Union

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number54040351HBL046P Basic UDI-DI Date29 Apr 2024RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / reference
HBL04(A, M), HBL04M, HBL04
Primary DI / UDI-DI
05404035100578, 05404035100561
Basic UDI-DI
54040351HBL046P
Direct marketing DI
05404035100578
05404035100561
EMDN code
W01010213 Glucose
Device class
Class B
EU registration type
Standard device
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000000033

Similar devices in this category

Other devices filed under GLUCOSE.

Other devices from Cypress Diagnostics

See all devices from Cypress Diagnostics →

Properties

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