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E-Link
EUDAMEDFDA UDIClass I (EU MDR)
Ref GX3 Myo-EX EMG Sensor (Wired) integral electrodes
Identity
- Trade Name
- E-LINK EUDAMEDE-LINK Myo-EX GX3 EMG Sensor FDA UDI
- Generic Name
- Kinesiology/electromyographic sensor set FDA UDI
- Device Name
- E-LINK Evaluation and Exercise Systems EUDAMEDHighly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint movement. GX3 sensor with integral electrodes is applied to the skin with die-cut medical grade hypoallergenic tape. Plastic connector for use with E-LINK X4 MkIV Interface Unit with plastic connectors. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 FDA UDI
- Model / Reference
- GX3 Myo-EX EMG Sensor (Wired) integral electrodes EUDAMEDGX3 FDA UDI
- Description
- Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint movement. GX3 sensor with integral electrodes is applied to the skin with die-cut medical grade hypoallergenic tape. Plastic connector for use with E-LINK X4 MkIV Interface Unit with plastic connectors. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 FDA UDI
Identifiers
- Catalog Number
- GX3 plastic connector FDA UDI
- Primary DI / UDI-DI
- 05060481690102 EUDAMEDFDA UDI
- Basic UDI-DI
- 506048169E-LINKY3 EUDAMED
- FDA Product Code
- ISD FDA UDIHCC FDA UDI
- EMDN Code
- Z12062401 ELECTROMYOGRAPHIC BIOFEEDBACK SYSTEMS EUDAMED
- GMDN Term
- Kinesiology/electromyographic sensor set FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5360 FDA UDI882.5050 FDA UDI
- Market of Registration
- Northern Ireland 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
E-Link by Biometrics Ltd — 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 | 506048169E-LINKY3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biometrics Ltd
- EUDAMED SRN
- GB-MF-000002774
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 3823953e-aa9f-420f-94e0-0f38656913b3 61 fields · synced Jul 22, 2026
- FDA UDI fb7e75b0-ce24-49d7-85c7-877b0a3e79b8 34 fields · synced May 30, 2026