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Kinetigram

by Bioniks

Ref 200-00201

Kinetigram (200-00201) is a medical device (EU MDR Class I; FDA Class I; FDA product code KQX, Goniometer, Ac-Powered; EMDN category medical device software - not included in other classes) made by Bioniks, registered in EUDAMED on 7 Apr 2026 (Basic UDI-DI 08600072865kinetigramTD) and listed in FDA GUDID since 29 Dec 2022 (UDI-DI 00860007286506), active as of 22 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08600072865kinetigramTD Basic UDI-DI 00860007286506UDI-DIDate7 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00860007286506 UDI-DI Date29 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08600072865kinetigramTD registered 7 Apr 2026 Active
  • FDA GUDID UDI-DI 00860007286506 listed 29 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00860007286506
  2. Registered EUDAMED 08600072865kinetigramTD

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  • Withdrawn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 / Ref / Catalog
200-00201 EUDAMED
v2 GUDID
200-00201-DO-01 GUDID
Primary DI / UDI-DI
00860007286506
Basic UDI-DI
08600072865kinetigramTD
FDA product code
KQX
EMDN code
V92 Medical device software - not included in other classes
GMDN term
Biomechanical function analysis/rehabilitation software
Device class
Class I
Regulation number
888.1500
Special device type
Software
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
200-00201
GUDID
v2

Manufacturer details

EUDAMED SRN
US-MF-000044597
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Similar devices in this category

Other devices filed under MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES.

Other devices from Bioniks

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)