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Hydrophilic Nelaton Catheter

by Integral Medical Products Co., Ltd. EUDAMED

Active European Union

Ref WHF16Model Hydrophilic Nelaton Catheter, PVC, Straight Tip

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-06970675359779 Basic UDI-DIDate13 Jul 2026RegisteredStatusActive
European UnionCE/MDD NumberB-06970675359779 Basic UDI-DIDate13 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Trade Name
KONTICUR® Kath H+F
Device Name
Hydrophilic Nelaton Catheter
Nelaton Catheter
Model / Reference
WHF16, Hydrophilic Nelaton Catheter, PVC, Straight Tip
Primary DI / UDI-DI
06970675359779
Basic UDI-DI
B-06970675359779, 697067535IMP2ASNNNSNCH1YG
EMDN Code
U01010501 Nelaton catheters, self-lubricating
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000009217
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

Show properties
  • 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