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Disposable Intermittent Catheter

by Chengdu Daxan Innovative Medical Tech.Co., Ltd China EUDAMED

Ref H09-16FSModel coated, with water sachet TPU catheter EMDN U01010501

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697197678DXACE0111VF Basic UDI-DIDate8 Jul 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  • Withdrawn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 23 Oct 2026

Model / Reference
coated, with water sachet TPU catheter, H09-16FS
Primary DI / UDI-DI
06942214104966
Basic UDI-DI
697197678DXACE0111VF
EMDN Code
U01010501 Nelaton catheters, self-lubricating
Device Class
Class I
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
CN-MF-000033805
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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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 7da9a971-e38f-4040-9a68-bdf3d02a656c 61 fields · synced 23 Oct 2026