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self FLOQSwabs

by Copan Italia S.P.A. Italy EUDAMED

Ref 5E089N.NL

EMDN A1101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08053326011191 Basic UDI-DIDate8 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Self-vaginal swab, 60mm marked breakpoint, peelable barcode
Model / Reference
5E089N.NL
Primary DI / UDI-DI
08053326011191
Basic UDI-DI
B-08053326011191
EMDN Code
A1101 Sample collection neutral swabs
Device Class
Class IIa
Market of Registration
Belgium

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
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 08053326011191|B-08053326011191 61 fields · synced 24 Oct 2026