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SQA-iO Test Kit

by MES Medical Electronic Systems LTD

Ref IO-CA-01680-00

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-07290016650419 Basic UDI-DI 07290016650419UDI-DIDate15 Oct 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  • Withdrawn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

Model / Reference
IO-CA-01680-00
Primary DI / UDI-DI
07290016650419
Basic UDI-DI
B-07290016650419
EMDN Code
W0101060204 Urine multi-constituent test strips (manual)
Device Class
Class IVD General
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
IL-MF-000034514
Authorised representative
Arazy Group GmbH DE-AR-000007685

Other devices from MES Medical Electronic Systems LTD

See all devices from MES Medical Electronic Systems LTD →

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