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PRO-Diary Motion

by CamNtech Ltd

Ref 05-111

PRO-Diary Motion (05-111) is a device classified as Class I in the EU and Class II in the US made by CamNtech Ltd, registered in EUDAMED on 26 Jan 2023 (Basic UDI-DI ++B329PDM01XT), cleared under FDA 510(k) K132764 on 21 Jan 2014 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI B329PDM25), 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++B329PDM01XT Basic UDI-DI B329PDM25UDI-DIDate26 Jan 2023RegisteredStatusActive
United StatesGUDID listing GUDID NumberB329PDM25 UDI-DI Date24 Sep 2016ListedStatusListed 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 ++B329PDM01XT registered 26 Jan 2023 Active
  • FDA 510(k) K132764 decided 21 Jan 2014 Active
  • FDA GUDID UDI-DI B329PDM25 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K132764
  2. Listed FDA GUDID B329PDM25
  3. Registered EUDAMED ++B329PDM01XT

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  • Withdrawn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
PRO-Diary Motion EUDAMED
PRO-Diary GUDID
Generic name
Kinesiology ambulatory recorder
Model / Ref / Catalog
05-111, PDM
Primary DI / UDI-DI
B329PDM25
Basic UDI-DI
++B329PDM01XT
Direct marketing DI
B329PDM25
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
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
05-111
GUDID
PDM
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)