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Kit Dia

by B.T.I. Biotechnology Institute, S.l Spain EUDAMED

Ref BTI DIA-S

EMDN Q03010299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number84353898KITDIAXL Basic UDI-DIDate17 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Kit Dia
Model / Reference
BTI DIA-S
Primary DI / UDI-DI
08435389813033
Basic UDI-DI
84353898KITDIAXL
EMDN Code
Q03010299 Antisnoring and obstructive sleep apnoea devices - other
Device Class
Class I
Medical Purpose
Indicated for the treatment of patients diagnosed with mild or moderate Obstructive Sleep Apnea (OSA) with an Apnoea-Hypopnoea Index (AHI) between 5 and 30.

Manufacturer details

EUDAMED SRN
ES-PR-000001719

Other devices from B.T.I. Biotechnology Institute, S.l

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Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 08435389813033|84353898KITDIAXL 61 fields · synced 24 Oct 2026