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Self FLOQSwabs

by Copan Italia S.P.A. Italy EUDAMED

Ref 5U197S

EMDN A1101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number80533260FD0542AM001EL Basic UDI-DIDate13 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Self FLOQSwabs- Rectal specimen collection and transport swab
Model / Reference
5U197S
Primary DI / UDI-DI
08053326011627
Basic UDI-DI
80533260FD0542AM001EL
EMDN Code
A1101 Sample collection neutral swabs
Device Class
Class IIa
Market of Registration
Italy

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 (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 08053326011627|80533260FD0542AM001EL 61 fields · synced 24 Oct 2026