E-LINK EX2 Interface Unit for M400

FDA UDI

Class II (US FDA UDI)

by Biometrics Limited

Identity

Trade Name: E-LINK EX2 Interface Unit for M400 FDA UDI
Generic Name: Medical networking interface unit FDA UDI
Device Name: The EX2 Interface Unit is used to connect the M400 Myo-EX (GX1, GX2) and AngleX (NC1, NC2) sensors to E3000 Serial Interface Upper Limb Exerciser. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13 FDA UDI
Model / Reference: EX2 FDA UDI
Description: The EX2 Interface Unit is used to connect the M400 Myo-EX (GX1, GX2) and AngleX (NC1, NC2) sensors to E3000 Serial Interface Upper Limb Exerciser. 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: 05060481692465 FDA UDI
FDA Product Code: HCC FDA UDI
ISD FDA UDI
BXB FDA UDI
ION FDA UDI
GMDN Term: Medical networking interface unit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5050 FDA UDI
890.5360 FDA UDI
890.5380 FDA UDI
890.5370 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

FDA UDI

Serial Number

Yes

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Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Medical networking interface unit

E-LINK EX2 Interface Unit for M400 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 76ec4b9e-321b-4ca0-9c49-e73f7bd157f0 33 fields · synced May 30, 2026