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Automatic Glycohemoglobin Analyzer

by Shenzhen Dake Medical Technology Co., Ltd EUDAMED

Active European Union

Ref Bright h800MaxModel Bright h600, Bright h600Pro, Bright h600Max, Bright h800, Bright h800Pro, Bright h800Max, Bright h1200, Bright h1200Pro, Bright h1200Max

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697846523AGAUL Basic UDI-DIDate7 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
Bright h600, Bright h600Pro, Bright h600Max, Bright h800, Bright h800Pro, Bright h800Max, Bright h1200, Bright h1200Pro, Bright h1200Max
Primary DI / UDI-DI
06978465236651
Basic UDI-DI
697846523AGAUL
EMDN Code
W0201060101 Glycosilated hemoglobin devices
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000047336
Authorised representative
HyperCert Limited B.V. NL-AR-000047746

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Properties

  • Professional Testing
  • Surgical Instrument

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
  • New Device: No