Skip to content

Silicone Hematuria Catheter, Couvelaire

by Fortune Medical Instrument Corp. 4 variants

Ref 1865-0318

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-04710961933854 Basic UDI-DI Date9 Apr 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  • Withdrawn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

Model / Reference
1865-0318
Primary DI / UDI-DI
04710961933854, 14710961933851
Basic UDI-DI
B-04710961933854, B-14710961933851
EMDN Code
U020299 Ureteral catheters with balloon - other
Device Class
Class IIb
EU market of registration
Poland
France

Manufacturer details

EUDAMED SRN
TW-MF-000009221
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Fortune Medical Instrument Corp.

See all devices from Fortune Medical Instrument Corp. →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No