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Glycated hemoglobin analyzer

by Changchun Chenyu Taikang Medical Laboratory Co., Ltd China EUDAMED

Ref N/A, TG-10Model TG-10,TG-60

EMDN W02020699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697736785GHA001NZ Basic UDI-DIDate25 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
TG-10, TG-60, N/A
Primary DI / UDI-DI
06977367850040, 06977367850033
Basic UDI-DI
697736785GHA001NZ
EMDN Code
W02020699 Rapid test hematology / histology / cytology instruments - other
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000046653
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
  • New Device YesEUDAMEDNoEUDAMED
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No

Sources (2)

  • EUDAMED ca3fac49-4a74-429e-ad74-511b9f08925f 61 fields · synced 22 Oct 2026
  • EUDAMED 06977367850033|697736785GHA001NZ 61 fields · synced 17 May 2026