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Disposable Midstream Urine Collection Device

by Hebei Sanxin Pharmaceutical Technology Co., Ltd. EUDAMED

Active European Union

Ref Type I·10 mL·50 set/bagModel Ⅰ 10mL Ⅰ 12mL Ⅰ 10mL Ⅰ 12mL Ⅱ 10mL Ⅱ 12mL Ⅱ 10mL Ⅱ 12mL

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697890768DMUCDXZ Basic UDI-DIDate2 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
Ⅰ 10mL Ⅰ 12mL Ⅰ 10mL Ⅰ 12mL Ⅱ 10mL Ⅱ 12mL Ⅱ 10mL Ⅱ 12mL, Type I·10 mL·50 set/bag
Primary DI / UDI-DI
06978907680271
Basic UDI-DI
697890768DMUCDXZ
EMDN Code
W05010299 Urine collection devices - other
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000057708
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

  • Professional Testing

Other properties (10)

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