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GDxDORCO 35H, HIGH PROFILE

by Gangdong Group Co., Ltd. South Korea EUDAMED

Ref 021-1302-1036Model 35H, High Profile, 35°, 50-pack EMDN W0202059085

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number08809772981126ZT Basic UDI-DIDate28 May 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
GDxDORCO MICROTOME BLADES
Model / Reference
35H, High Profile, 35°, 50-pack, 021-1302-1036
Primary DI / UDI-DI
08809772981126
Basic UDI-DI
08809772981126ZT
Direct Marketing DI
08809772981126
EMDN Code
W0202059085 Various processing instruments for hystology / cytology - consumables
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000021347
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Gangdong Group Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Surgical Instrument
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED af7a32a3-8a46-4782-a65a-a35b8a2b2a3a 61 fields · synced 22 Oct 2026