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Flocath Introgel Catheter for self-catheterisation (+lubricant, urine bag, insertion aid)

by Teleflex Medical 13 variants

Ref 851631-000080

Active European Union

CE MDR CE MDD

Valid until

Not listed

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

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/MDD Number08019020000000000000189L7 Basic UDI-DI Date11 Sep 2026RegisteredStatusActive
European UnionCE/MDR Number08019020000000000000189L7 Basic UDI-DI Date11 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD, CE/MDR Active

Specification

EUDAMED

Device Name
PVC Intermittent Catheters
Flocath Introgel Nelaton 8CH Paed.
Model / Reference
851631-000080
Primary DI / UDI-DI
14026704729392, 24026704100198
Basic UDI-DI
08019020000000000000189L7, B-24026704100198
EMDN Code
U01010502 Nelaton catheters, non self-lubricating
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000015868

Other devices from Teleflex Medical

See all devices from Teleflex Medical →

Properties

  • 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