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Transystem

by Copan Italia S.P.A. 57 variants

Ref 114CF167K.IS

Transystem (114CF167K.IS) is a medical device (EU MDD Class IIa; EMDN category sample collection swabs with transport medium) made by Copan Italia S.P.A., registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI B-18053326011273), active as of 7 Nov 2026.

Active European Union

CE MDD

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/MDD NumberB-18053326011273 Basic UDI-DI 18053326011273UDI-DIDate20 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Transystem Amies with Ch 2 Plastic Applicators Rayon Tipped
Model / reference
114CF167K.IS
Primary DI / UDI-DI
18053326011273
Basic UDI-DI
B-18053326011273
EMDN code
A1102 Sample collection swabs with transport medium
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000022535

Similar devices in this category

Other devices filed under SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM.

Other devices from Copan Italia S.P.A.

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

Properties

  • Supplied sterile
Other properties (11, all answered No)