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Inoculation Loops

by Copan Italia S.P.A. Italy EUDAMED

Ref 612-9355

EMDN W05030302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-612-93558H Basic UDI-DIDate19 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
SOFT LOOP 1 ul STERILE, IN BAGS OF 10 PCS
Model / Reference
612-9355
Primary DI / UDI-DI
D-612-93558H
Basic UDI-DI
B-612-93558H
EMDN Code
W05030302 Microbiological culture, loops
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
IT-MF-000022535

Other devices from Copan Italia S.P.A.

See all devices from Copan Italia S.P.A. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Professional Testing
Other properties (8)
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED d80488c7-5601-4cc4-a60b-509739c38d10 61 fields · synced 24 Oct 2026