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A1c Go HbA1c Control

by Goldsite Diagnostics Inc. China EUDAMED

Ref HBDMAC2

EMDN W0101050205

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06971225937966 Basic UDI-DIDate3 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
HBDMAC2
Primary DI / UDI-DI
06971225937966
Basic UDI-DI
B-06971225937966
EMDN Code
W0101050205 Diabetes controls
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000001353
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Goldsite Diagnostics Inc.

See all devices from Goldsite Diagnostics Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 5c9814f0-0351-4a16-ada3-e35d51cd1c86 61 fields · synced 24 Oct 2026