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Urinary Tract Infection (UTI) &DR Panel (Fluorescence PCR method)

by BioTeke Corporation（Wuxi）Co., Ltd 2 variants

Ref PR2024-UT01

Active European Union

CE IVDD

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974541565493 Basic UDI-DI 06974541565493UDI-DIDate18 May 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Device Name
Urinary Tract Infection (UTI) &DR Panel (Fluorescence PCR method)
Model / Reference
PR2024-UT01
Primary DI / UDI-DI
06974541565493
Basic UDI-DI
B-06974541565493
EMDN Code
W0105010111 Chlamydia trachomatis antibody igm
Device Class
Class IVD General
EU market of registration
Bulgaria

Manufacturer details

EUDAMED SRN
CN-MF-000007517
Authorised representative
Medunion S.L. ES-AR-000019366

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Properties

  • Professional Testing

Other properties (9)

  • 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