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BiopSafe®

by BiopSafe ApS Denmark EUDAMED

Ref 3178-200-13

EMDN W01030705

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5714678BiopSafeNG Basic UDI-DIDate17 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
BiopSafe® Biopsy Container
Model / Reference
3178-200-13
Primary DI / UDI-DI
05714678000020
Basic UDI-DI
5714678BiopSafeNG
Direct Marketing DI
05714678000020
EMDN Code
W01030705 Fixing reagents (histology/cytology)
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
DK-MF-000048467

Other devices from Biopsafe ApS

See all devices from Biopsafe ApS →

Properties & raw data

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

Sources (1)

  • EUDAMED d1e688fe-03ed-44f0-b748-38e821740e23 61 fields · synced 24 Oct 2026