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Ida

by iSTOC Oy

Ref 012016

Withdrawn Withdrawn in European Union.

Was authorized under CE IVDD, withdrawn

Ended

Withdrawn

Date not published (CE IVDD)

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-GMDN440824D Basic UDI-DI D-GMDN440824DUDI-DIDate10 Feb 2023RegisteredStatusWithdrawn

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  • Withdrawn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European Union — CE/IVDD Withdrawn

Specification

EUDAMED

Device Name
IDA Health
Model / Reference
012016
Primary DI / UDI-DI
D-GMDN440824D
Basic UDI-DI
B-GMDN440824D
EMDN Code
W0201020192 Automated immunochemistry analysers - IVD medical device software
Device Class
Class IVD General
Special Device Type
-1202
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000033355

Properties

  • Near-Patient Testing
  • Professional Testing
  • Companion Diagnostics

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Surgical Instrument: No