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Disposable Urine Specimen Sampler

by Hebei Sanxin Pharmaceutical Technology Co., Ltd. 8 variants

Ref Type Ⅱ·10 mL·1 set/bagModel Ⅰ 10mL Ⅰ 12mL Ⅰ 10mL Ⅰ 12mL Ⅱ 10mL Ⅱ 12mL Ⅱ 10mL Ⅱ 12mL

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697890768DUSSZP Basic UDI-DI 06978907680370UDI-DIDate2 Sep 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
Ⅰ 10mL Ⅰ 12mL Ⅰ 10mL Ⅰ 12mL Ⅱ 10mL Ⅱ 12mL Ⅱ 10mL Ⅱ 12mL, Type Ⅱ·10 mL·1 set/bag
Primary DI / UDI-DI
06978907680370
Basic UDI-DI
697890768DUSSZP
EMDN Code
W05010203 Urine collection, containers
Device Class
Class A
EU market of registration
Austria

Manufacturer details

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

Other devices from Hebei Sanxin Pharmaceutical Technology Co., Ltd.

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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