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BIP Foley Catheter - Silicone, 3-way 22 Fr 10cc

by Bactiguard AB 2 variants

Ref 116221020Model BIP Foley Catheter - Silicone

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

1 certificate

Certifier DEKRA Certification B.V.

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 Number7333330FOLEYSIL120101ZR Basic UDI-DI 07333330107860UDI-DIDate17 Mar 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2253382CE02 Cancelled

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    9 Feb 2024
    Expires
    1 Jan 2028
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
BIP Foley Catheter - Silicone
Model / Reference
BIP Foley Catheter - Silicone, 116221020
Primary DI / UDI-DI
07333330107860
Basic UDI-DI
7333330FOLEYSIL120101ZR
EMDN Code
U010299 Urethral prostatic and bladder catheters, with balloon - other
Device Class
Class IIb
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000020790

Related devices

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

Other devices from Bactiguard AB

See all devices from Bactiguard AB →

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