Identity
- Trade Name
- ActiGraph wGT3X-BT EUDAMEDActigraph FDA UDI
- Generic Name
- Kinesiology ambulatory recorder FDA UDI
- Device Name
- ActiGraph wGT3X-BT EUDAMEDThe wGT3X-BT is a body worn device that measures and records physical movement associated with daily activity and sleep. The wGT3X-BT is intended for use in applications where quantifiable measurement and storage of physical movement is desired. FDA UDI
- Model / Reference
- wGT3X-BT EUDAMEDFDA UDI
- Description
- The wGT3X-BT is a body worn device that measures and records physical movement associated with daily activity and sleep. The wGT3X-BT is intended for use in applications where quantifiable measurement and storage of physical movement is desired. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853048008008 EUDAMEDFDA UDI
- Basic UDI-DI
- 0853048008008UP EUDAMED
- Direct Marketing DI
- 00853048008008 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 wGT3X-BT 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 | 0853048008008UP | 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 4b199c3d-2897-4f0a-863a-ac9ca349f7b3 61 fields · synced Jul 13, 2026
- FDA UDI 5d63ffd7-a71b-49b0-bc57-ee443362f8e5 35 fields · synced May 30, 2026