E-LINK X4 Interface Unit

FDA UDI

Class I (US FDA UDI)

by Biometrics Limited

Identity

Trade Name: E-LINK X4 Interface Unit FDA UDI
Generic Name: Medical networking interface unit FDA UDI
Device Name: The X4 InterX Unit functions as the intelligent interface to connect the E-LINK evaluation and exercise modules to the computer via the USB port. Up to four E-LINK devices may be connected simultaneously allowing the user to easily and quickly switch between them during an evaluation or exercise session. Includes Medical Grade Power Supply and country specific mains power cord. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13 FDA UDI
Model / Reference: X4 FDA UDI
Description: The X4 InterX Unit functions as the intelligent interface to connect the E-LINK evaluation and exercise modules to the computer via the USB port. Up to four E-LINK devices may be connected simultaneously allowing the user to easily and quickly switch between them during an evaluation or exercise session. Includes Medical Grade Power Supply and country specific mains power cord. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13 FDA UDI

Identifiers

Catalog Number: X4 MkII metal connectors FDA UDI
Primary DI / UDI-DI: 05060481690492 FDA UDI
FDA Product Code: ION FDA UDI
BXB FDA UDI
ISD FDA UDI
HCC FDA UDI
GMDN Term: Medical networking interface unit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.5370 FDA UDI
890.5380 FDA UDI
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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Medical networking interface unit

E-LINK X4 Interface Unit by Biometrics Limited — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Biometrics Limited

Sources (1)

FDA UDI b352a2ed-5085-4e10-bbfd-4e1fcef1595f 34 fields · synced May 31, 2026