Identity
- Trade Name
- KinesiaU (iOS) FDA UDI
- Generic Name
- Tremor transducer FDA UDI
- Device Name
- Kinesia ONE EUDAMED
- Model / Reference
- Kinesia U - 700-0026 EUDAMED700-0026 FDA UDI
Identifiers
- Catalog Number
- 700-0026 FDA UDI
- Primary DI / UDI-DI
- 00859584006102 EUDAMEDFDA UDI
- Basic UDI-DI
- 0859584006KinesiaWG EUDAMED
- Direct Marketing DI
- 00859584006102 EUDAMED
- 510(k) Number
- K063872 FDA UDI
- FDA Product Code
- GYD FDA UDI
- EMDN Code
- W01010899 MULTIPLE PARAMETER - ELECTRODES/BIOSENSORS - OTHER EUDAMED
- GMDN Term
- Tremor transducer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1950 FDA UDI
- Market of Registration
- Spain 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Kinesia ONE by Great Lakes NeuroTechnologies Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0859584006KinesiaWG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Great Lakes NeuroTechnologies Inc
- EUDAMED SRN
- US-MF-000031444
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (2)
- EUDAMED 96cc9223-664d-476a-86b7-81b6b6d2433a 61 fields · synced Jul 25, 2026
- FDA UDI 80c202ee-de20-4ea5-9ca5-d8ae68096ded 34 fields · synced May 30, 2026