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E-LINK Myo-EX GX3 EMG Sensor

FDA UDI

Class II (US FDA UDI)

by Biometrics Limited

Identity

Trade Name
E-LINK Myo-EX GX3 EMG Sensor FDA UDI
Generic Name
Kinesiology/electromyographic sensor set FDA UDI
Device Name
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. Metal connector for use with E-LINK X4 MkI or MkII Interface Unit with metal connectors. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13 FDA UDI
Model / Reference
GX3 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. Metal connector for use with E-LINK X4 MkI or MkII Interface Unit with metal connectors. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13 FDA UDI

Identifiers

Catalog Number
GX3 metal connector FDA UDI
Primary DI / UDI-DI
05060481690508 FDA UDI
FDA Product Code
HCC FDA UDI
ISD FDA UDI
GMDN Term
Kinesiology/electromyographic sensor set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5050 FDA UDI
890.5360 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Category: Kinesiology/electromyographic sensor set

E-LINK Myo-EX GX3 EMG Sensor by Biometrics Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Kinesiology/electromyographic sensor set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biometrics Limited

Sources (1)

  • FDA UDI 00eb8fe4-7c85-4895-be3b-cd45f1c79a98 34 fields · synced May 30, 2026