Identity
- Trade Name
- ActiGraph GT9X EUDAMEDActiGraph FDA UDI
- Generic Name
- Kinesiology ambulatory recorder FDA UDI
- Device Name
- ActiGraph GT9X Link EUDAMEDThe GT9X is a body worn device that measures and records physical movement associated with daily activity and sleep. The GT9X is intended for use in applications where quantifiable measurement and storage of physical movement is desired. FDA UDI
- Model / Reference
- GT9X EUDAMEDFDA UDI
- Description
- The GT9X is a body worn device that measures and records physical movement associated with daily activity and sleep. The GT9X is intended for use in applications where quantifiable measurement and storage of physical movement is desired. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853048008015 EUDAMEDFDA UDI
- Basic UDI-DI
- 0853048008015UL EUDAMED
- Direct Marketing DI
- 00853048008015 EUDAMED
- 510(k) Number
- K080545 FDA UDI
- FDA Product Code
- ISD FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Kinesiology ambulatory recorder FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5360 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Device sterilization/disinfection container, reusable
ActiGraph GT9X by ActiGraph — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0853048008015UL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ActiGraph
- EUDAMED SRN
- US-MF-000007954
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4465b4d6-8f47-467d-9ff7-bc6b5359c3bd 61 fields · synced Jul 23, 2026
- FDA UDI 19ec4403-6a51-4538-acb3-573d90ef1215 35 fields · synced May 30, 2026