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Asthma Calculator

by Orla DTx Oy

Ref Asthma Calculator

Active European Union

CE MDR

Valid until

5 Feb 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS FIMKO OY

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6429811352AC_01ZL Basic UDI-DI 06429811352001UDI-DIDate23 Feb 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • FI26/00000015 Active

    Quality management system EU MDR

    Certifier
    SGS FIMKO OY 0598
    Issued
    6 Feb 2026
    Expires
    5 Feb 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Asthma Calculator
Model / Reference
Asthma Calculator
Primary DI / UDI-DI
06429811352001
Basic UDI-DI
6429811352AC_01ZL
Direct Marketing DI
06429811352001
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Special Device Type
Software
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000041810

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