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Mono-Flo Drainage Bag 100% Silicone Foley Catheter, Pre-conncected 18 Fr/Ch (6.0 mm), 2000 mL

by Covidien llc

Ref 6209181

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-10884521539624 Basic UDI-DI 10884521539624UDI-DIDate25 May 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  • Withdrawn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
Mono-Flo Drainage Bag 100% Silicone Foley Catheter, Pre-conncected 18 Fr/Ch (6.0 mm), 2000 mL
Model / Reference
6209181
Primary DI / UDI-DI
10884521539624
Basic UDI-DI
B-10884521539624
EMDN Code
U0199 Urethral prostatic and bladder catheters - other
Device Class
Class IIb
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000017721
Authorised representative
Covidien Ireland Limited IE-AR-000002274

Other devices from Covidien llc

See all devices from Covidien llc →

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