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Kaio-Dia

by Cv Angrrek Liar 953 variants

Ref UA-SE254DP-466-SModel Adjustable support armband for the Guardian Enlite glucose sensor

Active European Union

CE MDR

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/MDR Number8994228UA-SE254DDZ Basic UDI-DI 08994228068763UDI-DIDate7 Nov 2024RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Dia-Style adjustable support armband - Guardian Enlite Medtronic
Model / Reference
Adjustable support armband for the Guardian Enlite glucose sensor, UA-SE254DP-466-S
Primary DI / UDI-DI
08994228068763
Basic UDI-DI
8994228UA-SE254DDZ
EMDN Code
Z12040180 General medicine diagnosis and monitoring instruments - hardware accessories
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
ID-MF-000037819
Authorised representative
Kaio-Dia FR-AR-000037267

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No