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ActiGraph LEAP

by ActiGraph

Ref LEAP

ActiGraph LEAP is a kinesiology ambulatory recorder (EU MDR Class I; FDA Class II; FDA product code LEL, Device, Sleep Assessment) made by ActiGraph, registered in EUDAMED on 28 Mar 2024 (Basic UDI-DI 0853048008053UU), cleared under FDA 510(k) K231532 on 23 Jun 2023 and listed in FDA GUDID since 24 Apr 2024 (UDI-DI 00853048008053), 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) K231532

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00853048008053 UDI-DI Date24 Apr 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0853048008053UU Basic UDI-DI 00853048008053UDI-DIDate28 Mar 2024RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK231532 Date23 Jun 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0853048008053UU registered 28 Mar 2024 Active
  • FDA 510(k) K231532 decided 23 Jun 2023 Active
  • FDA GUDID UDI-DI 00853048008053 listed 24 Apr 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K231532
  2. Registered EUDAMED 0853048008053UU
  3. Listed FDA GUDID 00853048008053

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  • Withdrawn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 LEAP EUDAMED
ActiGraph GUDID
Generic name
Kinesiology ambulatory recorder
Model / Ref / Catalog
LEAP
Primary DI / UDI-DI
00853048008053
Basic UDI-DI
0853048008053UU
Direct marketing DI
00853048008053
510(k) Number
FDA product code
LEL
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
882.5050
EU registration type
Standard device
EU market of registration
Austria
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

See all devices from ActiGraph →

Properties

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