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Romed® Foley balloon catheters (latex), 2-way paediatric, 5 ml, 8 Ch

by Van Oostveen Medical B.V.

Ref CATH05-08Model 871720243MDIIAUCFDS0001LA

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 Number871720243MDIIAUCFDS0001LA Basic UDI-DI 08717202432936UDI-DIDate28 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Romed® Foley balloon catheters
Model / Reference
871720243MDIIAUCFDS0001LA, CATH05-08
Primary DI / UDI-DI
08717202432936
Basic UDI-DI
871720243MDIIAUCFDS0001LA
EMDN Code
U010201 Urethral prostatic and bladder catheters, nelaton, with balloon
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000003481

Other devices from Van Oostveen Medical B.V.

See all devices from Van Oostveen Medical B.V. →

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