Skip to content

Glucose Fl

by Chema Diagnostica Srl 2 variants

Ref GL 6U448

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

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

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

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-08033650845259 Basic UDI-DI 08033650845259UDI-DIDate28 Jul 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-08033650845259 Basic UDI-DI 08033650845259UDI-DIDate28 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Active

Specification

EUDAMED

Model / Reference
GL 6U448
Primary DI / UDI-DI
08033650845259
Basic UDI-DI
B-08033650845259, 803365084GLS9
Direct Marketing DI
08033650845259
EMDN Code
W01010213 Glucose
Device Class
Class IVD General
Class B
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000009128

Other devices from Chema Diagnostica Srl

See all devices from Chema Diagnostica Srl →

Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No