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Aquaflate Glycerine Silicone Balloon Catheter with Pre-filled Syringe

by Teleflex Medical Sdn. Bhd. 12 variants

Ref 178305-000180

Active European Union

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-24026704324044 Basic UDI-DI 24026704324044UDI-DIDate10 Jul 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  • Withdrawn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 Active

Specification

EUDAMED

Device Name
Aquafl Silicone 2W 10ml Tiemann
Model / Reference
178305-000180
Primary DI / UDI-DI
24026704324044
Basic UDI-DI
B-24026704324044
EMDN Code
U010206 Urethral prostatic and bladder catheters, tiemann with balloon
Device Class
Class IIb
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

  • 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