ActiGraph
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000007954
ActiGraph is a medical device manufacturer based in the United States, with 7 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class I; FDA Class II) as of 15 Nov 2026.
- Devices
- 7
- Registrations
- EUDAMED
Registry facts
- Registries
- EUDAMED 4
- FDA GUDID 4
- FDA 510(k) 3
- Device classes
- EU Class I 4
- FDA Class II 3
- Top EMDN categories
- Sites and related companies
- Emergo Europe B.V. authorised representative
- Identifiers
- EUDAMED SRN US-MF-000007954
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- Emergo Europe B.V.NL
Catalogue
ActiGraph CentrePoint Insight Watch Ref K181077
Regimes: 510(k) Registry: 510(k)Actitrainer Ref K080545
Regimes: 510(k) Registry: 510(k)ActiGraph LEAP activity monitor (ActiGraph LEAP) Ref K231532
Regimes: CE MDR 510(k) Registry: 510(k)- Regimes: CE MDR Registry: EUDAMEDGUDID
- Regimes: CE MDR Registry: EUDAMEDGUDID
- Regimes: CE MDR Registry: EUDAMEDGUDID
- Regimes: CE MDR Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- US-MF-000007954
- EUDAMED status
- Active
- EUDAMED registered name
- ActiGraph
- Registered address
- 70, North Baylen Street, 32502, Pensacola, United States
- Website
- actigraphcorp.com
- facebook.com/actigraphcorp
- Phone
- 8503327900
- PRRC contact
- Brian Bell
From the company website
We're pioneering the digital transformation of clinical research. Learn about our wearable digital health technology (DHT) solutions.
Frequently asked questions
How many devices does ActiGraph have in the registry?
The registry currently lists 7 devices for ActiGraph. Devices recorded under merged duplicate company entries are counted once.
Which registries list ActiGraph's devices?
Among its 7 most recently registered devices, ActiGraph has devices listed in EUDAMED (4 devices), FDA 510(k) (3 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ActiGraph's devices fall under?
Among its 7 most recently registered devices, the classes recorded for ActiGraph's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from ActiGraph in the registry?
The most recently registered devices listed for ActiGraph include ActiGraph CentrePoint Insight Watch, ACTITRAINER, ActiGraph LEAP activity monitor (ActiGraph LEAP) and ActiGraph wGT3X-BT.