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Self FLOQSwabs

by Copan Italia S.P.A. 17 variants

Ref 5U205N01

Self FLOQSwabs (5U205N01) is a medical device (EU MDR Class IIa; EMDN category sample collection neutral swabs) made by Copan Italia S.P.A., registered in EUDAMED on 13 Apr 2026 (Basic UDI-DI 80533260FD045P2M001MH), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number80533260FD045P2M001MH Basic UDI-DI 18053326011877UDI-DIDate13 Apr 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
SELF FLOQSwabs - Vaginal Specimen self-collection and transport swab
Model / reference
5U205N01
Primary DI / UDI-DI
18053326011877
Basic UDI-DI
80533260FD045P2M001MH
EMDN code
A1101 Sample collection neutral swabs
Device class
Class IIa
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000022535

Similar devices in this category

Other devices filed under SAMPLE COLLECTION NEUTRAL SWABS.

Other devices from Copan Italia S.P.A.

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

Properties

Other properties (14, all answered No)