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Fixup™

by Gangdong Group Co., Ltd. South Korea EUDAMED

Ref 0297 EMDN W05020199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number880977298FIXUP00D2 Basic UDI-DIDate18 Mar 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
0297
Primary DI / UDI-DI
08809772980297
Basic UDI-DI
880977298FIXUP00D2
Direct Marketing DI
08809772980297
EMDN Code
W05020199 Samples transport, containers - other
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
KR-MF-000021347
Authorised representative
ExFDA EU Auth Rep S.L.U. ES-AR-000021113

Other devices from Gangdong Group Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 488159f7-b22f-4e36-b1c3-7c167da7e3b1 61 fields · synced 22 Oct 2026