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Urine Container

by Taizhou Kangwei Medical Instrument Co., Ltd. 20 variants

Ref 180mlModel 5ml/10m/12ml/15ml/20ml/25ml/30ml/40ml/60ml/80ml/90ml/100ml/ 120ml/160ml/170ml/180ml/ 250ml/500ml/1L/2L

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697826803KWUCVM Basic UDI-DI 06978268031958UDI-DIDate22 Jan 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Urine Container
Model / Reference
5ml/10m/12ml/15ml/20ml/25ml/30ml/40ml/60ml/80ml/90ml/100ml/ 120ml/160ml/170ml/180ml/ 250ml/500ml/1L/2L, 180ml
Primary DI / UDI-DI
06978268031958
Basic UDI-DI
697826803KWUCVM
EMDN Code
W05010203 Urine collection, containers
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000045900
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

Other properties (11)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No