Skip to content

MotionWatch R

by CamNtech Ltd

Ref 04-121

MotionWatch R (04-121) is a device classified as Class I in the EU and Class II in the US made by CamNtech Ltd, registered in EUDAMED on 25 Jan 2023 (Basic UDI-DI ++B329MTN012J), cleared under FDA 510(k) K132764 on 21 Jan 2014 and listed in FDA GUDID since 2 Nov 2018 (UDI-DI B329MWR50), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132764

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++B329MTN012J Basic UDI-DI B329MWR50UDI-DIDate25 Jan 2023RegisteredStatusActive
United StatesGUDID listing GUDID NumberB329MWR50 UDI-DI Date2 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK132764 Date21 Jan 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++B329MTN012J registered 25 Jan 2023 Active
  • FDA 510(k) K132764 decided 21 Jan 2014 Active
  • FDA GUDID UDI-DI B329MWR50 listed 2 Nov 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K132764
  2. Listed FDA GUDID B329MWR50
  3. Registered EUDAMED ++B329MTN012J

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
MotionWatch R EUDAMED
MotionWatch GUDID
Generic name
Kinesiology ambulatory recorder
Model / Ref / Catalog
04-121, MW-R
Primary DI / UDI-DI
B329MWR50
Basic UDI-DI
++B329MTN012J
Direct marketing DI
B329MWR50
510(k) Number
FDA product code
LEL
EMDN code
Z12040199 General medicine diagnosis and monitoring instruments - other
GMDN term
Kinesiology ambulatory recorder
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.5050
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
04-121
GUDID
MW-R
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
GB-MF-000004683
Authorised representative
QbD RepS BV BE-AR-000000040

Similar devices in this category

Other devices filed under GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER.

Other devices from CamNtech Ltd

See all devices from CamNtech Ltd →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)