Skip to content

StepWatch

by Modus Health, LLC 2 variants

Ref 40517

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00860007307515 UDI-DI Date8 Sep 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number08600073075StepWatchGY Basic UDI-DI 00860007307515UDI-DIDate26 Jul 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Kinesiology ambulatory recorder
Model / Reference
40517 EUDAMED
StepWatch5 GUDID
Primary DI / UDI-DI
00860007307515
Basic UDI-DI
08600073075StepWatchGY
Direct Marketing DI
00860007307515
FDA Product Code
IKK
EMDN Code
Z120602 Physiotherapy equipment
GMDN Term
Kinesiology ambulatory recorder
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
890.1925
EU market of registration
Norway
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
40517
GUDID
StepWatch5
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000026340
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Modus Health, LLC

Properties

  • Premarket Exempt
  • Serial Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No