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Hydrophilic Silicone Foley Catheter

by Hunan Reborn Medical Science and Technology Development Co., Ltd China EUDAMED

Ref three-lumen H type 22Ch/Fr open end straight tip 50mL

EMDN U0204

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69599565HSFC6P Basic UDI-DIDate12 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
three-lumen H type 22Ch/Fr open end straight tip 50mL
Primary DI / UDI-DI
06959956537785
Basic UDI-DI
69599565HSFC6P
EMDN Code
U0204 Transilluminating ureteral catheters
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000023648
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Hunan Reborn Medical Science and Technology Development Co., Ltd

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Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 2620fc3d-e4d6-4072-82d5-61df4d3d44ad 61 fields · synced 24 Oct 2026