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OKKO Health App

by Okulo Ltd

Ref OKKO-001Model OKKO Health App - android, OKKO Health App - ios

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 Number5065012821017S4 Basic UDI-DI Date20 Aug 2025RegisteredStatusActive

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  • Withdrawn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
OKKO Health App - android
OKKO Health App - ios
Model / Reference
OKKO Health App - android, OKKO-001, OKKO Health App - ios
Primary DI / UDI-DI
15065012821014, 15065012821007
Basic UDI-DI
5065012821017S4, 5065012821000RK
Direct Marketing DI
15065012821014
15065012821007
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class I
Special Device Type
Software
EU market of registration
Portugal

Manufacturer details

EUDAMED SRN
UK-MF-000039219
Authorised representative
OKKO Health Ireland Trading Ltd XI-AR-000032953

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