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Glycated hemoglobin test kit (High-performance liquid chromatography)

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

Ref 400 testsModel 400 tests,1000 tests EMDN W010106020301

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06977367850019 Basic UDI-DIDate25 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Glycated hemoglobin test kit (High-performance liquid chromatography)
Model / Reference
400 tests, 1000 tests
Primary DI / UDI-DI
06977367850019
Basic UDI-DI
B-06977367850019
EMDN Code
W010106020301 Urine sediment test kit (manual)
Device Class
Class IVD General
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
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 7ed30238-b13c-4437-bee0-95aa66706103 61 fields · synced 22 Oct 2026