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Ruecco Neo Male External Catheter

by Teleflex Medical Sdn. Bhd. 5 variants

Ref 854410-000200

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08019020000000000000018KB Basic UDI-DI 24026704716092UDI-DIDate3 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
854410-000200
Primary DI / UDI-DI
24026704716092
Basic UDI-DI
08019020000000000000018KB
Unit of Use DI
14026704716095
EMDN Code
U070201 Sheath catheter for the treatment of incontinence
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
MY-MF-000024692
Authorised representative
Teleflex Medical IE-AR-000015869

Other devices from Teleflex Medical Sdn. Bhd.

See all devices from Teleflex Medical Sdn. Bhd. →

Properties

Other properties (13)

  • Sterile: No
  • 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