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A-800 Glucose Hex

by PZ CORMAY Spółka Akcyjna

Ref 7-802, 7-801Model A-800 GLUCOSE HEX, A-800 GLUCOSE

Active European Union

CE IVDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05907514678020 Basic UDI-DI Date21 Jul 2025RegisteredStatusActive

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  • Withdrawn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

Trade Name
A-800 Glucose Hex
A-800 Glucose
Device Name
Glucose Hex
Glucose
Model / Reference
A-800 GLUCOSE HEX, 7-802, A-800 GLUCOSE, 7-801
Primary DI / UDI-DI
05907514678020, 05907514678013
Basic UDI-DI
B-05907514678020, B-05907514678013
EMDN Code
W01010213 Glucose
Device Class
Class IVD General
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000023053

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Properties

  • Animal Tissues NoEUDAMEDYesEUDAMED
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (6)

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