Skip to content

Streck Urine Preserve CE

by Streck 2 variants

Ref 230631

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 Number08445090UPCENV Basic UDI-DI 00844509002390UDI-DIDate27 Jun 2022RegisteredStatusActive

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  • Withdrawn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
230631
Primary DI / UDI-DI
00844509002390
Basic UDI-DI
08445090UPCENV
Unit of Use DI
00844509002383
EMDN Code
W0580 IVD general use consumables devices - other accessories
Device Class
Class A
EU market of registration
France

Manufacturer details

EUDAMED SRN
US-MF-000013009
Authorised representative
MediMark Europe Sarl. FR-AR-000000182

Other devices from Streck

  • Cell-Free DNA BCT CE

    Class A

  • Xn Check Bf

    Class II

  • Cell-Free DNA BCT

    Class II

  • Xn Check

    Class II

  • Xn Cal

    Class II

  • Xn-L Check

    Class II

See all devices from Streck →

Properties

  • Reagent

Other properties (10)

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