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KinetikOS

by Kinetikos - Driven Solutions, Lda

Ref KinetikOS

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number560063878182KinetikOS76 Basic UDI-DI 05600638781828UDI-DIDate4 May 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number05600638781828 UDI-DI Date22 Nov 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Biomechanical function analysis/rehabilitation software
Model / Reference
KinetikOS EUDAMED
0 GUDID
1 GUDID
Primary DI / UDI-DI
05600638781828
Basic UDI-DI
560063878182KinetikOS76
Direct Marketing DI
05600638781828
FDA Product Code
ISD
EMDN Code
V92 Medical device software - not included in other classes
GMDN Term
Biomechanical function analysis/rehabilitation software
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
890.5360
Special Device Type
Software
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
KinetikOS
GUDID
0,1
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
PT-MF-000012965

Other devices from Kinetikos - Driven Solutions, Lda

Properties

  • Over-the-Counter
  • Premarket Exempt

Other properties (22)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No