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GDxDORCO 35L, LOW PROFILE

by Gangdong Group Co., Ltd. South Korea EUDAMED

Ref 021-1302-1035Model 35L, Low Profile, 35°, 50-pack EMDN W0202059085

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number08809772981034ZM 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  • Withdrawn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
35L, Low Profile, 35°, 50-pack, 021-1302-1035
Primary DI / UDI-DI
08809772981034
Basic UDI-DI
08809772981034ZM
Direct Marketing DI
08809772981034
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 dc281e5c-7ed2-4fad-82a7-ec02a6f94508 61 fields · synced 22 Oct 2026