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Bti Apnia Software

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

Ref APNIA SOFTWARE

EMDN Z12159099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number84353898APNIA-SOFTAG Basic UDI-DIDate21 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Bti Apnia Software
Model / Reference
APNIA SOFTWARE
Primary DI / UDI-DI
08435389824220
Basic UDI-DI
84353898APNIA-SOFTAG
Direct Marketing DI
08435389824220
EMDN Code
Z12159099 Various pneumology and respiratory physiopathology instruments - other
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000001701

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

See all devices from B.T.I. Biotechnology Institute, S.l →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 08435389824220|84353898APNIA-SOFTAG 61 fields · synced 25 Oct 2026