E-LINK Myo-EX GX1 EMG Sensor

FDA UDI

Class II (US FDA UDI)

by Biometrics Limited

Identity

Trade Name: E-LINK Myo-EX GX1 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. GX1 sensor with integral electrodes is applied to the skin with die-cut medical grade hypoallergenic tape. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13 FDA UDI
Model / Reference: GX1 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. GX1 sensor with integral electrodes is applied to the skin with die-cut medical grade hypoallergenic tape. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13 FDA UDI

Identifiers

Primary DI / UDI-DI: 05060481692441 FDA UDI
FDA Product Code: ISD FDA UDI
HCC FDA UDI
GMDN Term: Kinesiology/electromyographic sensor set FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Kinesiology/electromyographic sensor set

E-LINK Myo-EX GX1 EMG Sensor by Biometrics Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Biometrics Limited

Sources (1)

FDA UDI a37bcbdb-9360-4de6-931b-ddc94194a4b7 33 fields · synced May 30, 2026