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Foley Trac (2 Way)

by Romsons Group Private Limited 5 variants

Ref GS 1022

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 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/MDR Number8907265A010Y4 Basic UDI-DI Date14 Jun 2025RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Foley Balloon Catheter (Latex)
Model / Reference
GS 1022
Primary DI / UDI-DI
08907265102215, 08907265102208, 08907265102222
Basic UDI-DI
8907265A010Y4
EMDN Code
U010299 Urethral prostatic and bladder catheters, with balloon - other
Device Class
Class IIa
EU market of registration
Austria
Belgium

Manufacturer details

EUDAMED SRN
IN-MF-000036506
Authorised representative
Obelis s.a. BE-AR-000000106

Related devices

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

Other devices from Romsons Group Private Limited

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Properties

  • Sterile
  • Contains Latex

Other properties (11)

  • Implantable: No
  • Reusable: 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