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ActiGraph wGT3X-BT

by ActiGraph

Ref wGT3X-BT

ActiGraph wGT3X-BT is a kinesiology ambulatory recorder (EU MDR Class I; FDA Class II; FDA product code ISD, Exerciser, Measuring) made by ActiGraph, registered in EUDAMED on 10 May 2022 (Basic UDI-DI 0853048008008UP), cleared under FDA 510(k) K080545 on 24 Jul 2008 and listed in FDA GUDID since 28 Dec 2017 (UDI-DI 00853048008008), 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) K080545

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 Number0853048008008UP Basic UDI-DI 00853048008008UDI-DIDate10 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00853048008008 UDI-DI Date28 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK080545 Date24 Jul 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0853048008008UP registered 10 May 2022 Active
  • FDA 510(k) K080545 decided 24 Jul 2008 Active
  • FDA GUDID UDI-DI 00853048008008 listed 28 Dec 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K080545
  2. Listed FDA GUDID 00853048008008
  3. Registered EUDAMED 0853048008008UP

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  • Withdrawn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
ActiGraph wGT3X-BT EUDAMED
Actigraph GUDID
Generic name
Kinesiology ambulatory recorder
Model / reference
wGT3X-BT
Primary DI / UDI-DI
00853048008008
Basic UDI-DI
0853048008008UP
Direct marketing DI
00853048008008
510(k) Number
FDA product code
ISD
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Kinesiology ambulatory recorder
Device class
Class I EUDAMED
Class II GUDID
Regulation number
890.5360
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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
US-MF-000007954
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Device sterilization/disinfection container, reusable

Similar devices in this category

Other devices filed under VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER.

Other devices from ActiGraph

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Properties

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