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bt products Auto-HbA1C CALIBRATOR FIVE (5) LEVEL

by Bi̇li̇msel Tibbi̇ Ürünler Pazarlama Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

Ref GLYCAL-101Model GLYCAL-10

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08697643492006 Basic UDI-DI 08697643492006UDI-DIDate22 Sep 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Auto-HbA1C CALIBRATOR FIVE (5) LEVEL
Model / Reference
GLYCAL-10, GLYCAL-101
Primary DI / UDI-DI
08697643492006
Basic UDI-DI
B-08697643492006
EMDN Code
W0101050205 Diabetes controls
Device Class
Class IVD General
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000017223

Other devices from Bi̇li̇msel Tibbi̇ Ürünler Pazarlama Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

See all devices from Bi̇li̇msel Tibbi̇ Ürünler Pazarlama Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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