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Sterile Urethral Catheters for single use

by Shandong Caremed Medical Products Co., Ltd. China EUDAMED

Ref 10FrModel 6Fr,8Fr,10Fr,12Fr,14Fr,16Fr,18Fr,20Fr,22Fr,24Fr,26Fr,28Fr,30Fr EMDN U010201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697652354DNG001H5 Basic UDI-DIDate28 Aug 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Sterile Urethral Catheters for single use
Model / Reference
6Fr, 8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, 24Fr, 26Fr, 28Fr, 30Fr
Primary DI / UDI-DI
06976523543239, 06976523543246
Basic UDI-DI
697652354DNG001H5
EMDN Code
U010201 Urethral prostatic and bladder catheters, nelaton, with balloon
Device Class
Class IIa
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000033413
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shandong Caremed Medical Products Co., Ltd

See all devices from Shandong Caremed Medical Products Co., Ltd →

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 (2)

  • EUDAMED 23400e14-92af-4950-89b2-c4cee34cd1d4 61 fields · synced 22 Oct 2026
  • EUDAMED 06976523543246|697652354DNG001H5 61 fields · synced 18 May 2026