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Disposable Intermittent Catheter

by Chengdu Daxan Innovative Medical Tech.Co., Ltd 444 variants

Ref H09-16MSModel coated, with water sachet TPU catheter

Active European Union

CE MDR

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

Overview

This disposable intermittent catheter is designed for safe and effective insertion into the urinary tract, providing reliable performance in various medical applications. For detailed product information and instructions on proper use, refer to our comprehensive documentation.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697197678DXACE0111VF Basic UDI-DI 06942214104874UDI-DIDate8 Jul 2024RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Model / Reference
coated, with water sachet TPU catheter, H09-16MS
Primary DI / UDI-DI
06942214104874
Basic UDI-DI
697197678DXACE0111VF
EMDN Code
U01010501 Nelaton catheters, self-lubricating
Device Class
Class I
EU market of registration
Denmark

Manufacturer details

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

Related devices

Category: Intermittent urethral drainage catheter, non-antimicrobial, single-use

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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