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PathoLock™ 10% NBF (130 mL)

by Gangdong Group Co., Ltd. South Korea EUDAMED

Ref 020-1619-1130Model SINGLE-USE PRE-FILLED SAFETY CONTAINER WITH 10% NEUTRAL BUFFERED FORMALIN, NON-CONTACT MECHANICAL CAP-CLOSURE RELEASE, FOR FIXATION AND TRANSPORT OF HISTOLOGICAL SPECIMENS EMDN W01030705

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number088097729814782Y Basic UDI-DIDate1 Jun 2026RegisteredStatusActive

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  • Withdrawn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 25 Oct 2026

Device Name
PATHOLOCK™ 130 mL
Model / Reference
SINGLE-USE PRE-FILLED SAFETY CONTAINER WITH 10% NEUTRAL BUFFERED FORMALIN, NON-CONTACT MECHANICAL CAP-CLOSURE RELEASE, FOR FIXATION AND TRANSPORT OF HISTOLOGICAL SPECIMENS, 020-1619-1130
Primary DI / UDI-DI
08809772981478
Basic UDI-DI
088097729814782Y
Direct Marketing DI
08809772981478
EMDN Code
W01030705 Fixing reagents (histology/cytology)
Device Class
Class A
Market of Registration
Spain

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
  • 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 f580a4d4-7ef2-4170-8fb4-52156a24fc1c 61 fields · synced 25 Oct 2026