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CombiScreen® mALB / CREA

by Analyticon Biotechnologies GmbH

Ref 94025

Active European Union

CE IVDR

Valid until

1 Dec 2029

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

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 NumberV76 077568 0009 Date27 Nov 2025IssuedStatusActive EUDAMED: not on the EU market expires 1 Dec 2029

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • V76 077568 0009 Active

    Technical documentation EU IVDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    27 Nov 2025
    Expires
    1 Dec 2029
    Valid from
    1 Dec 2025

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Urine test strips for visual and semi-automated evaluation
Model / Reference
94025
Primary DI / UDI-DI
04260033710208
Basic UDI-DI
426003371CSLY
EMDN Code
W0101060204 Urine multi-constituent test strips (manual)
Device Class
Class B
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000016251

Other devices from Analyticon Biotechnologies GmbH

  • PM-U10-Test

    Class B

Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No