DataLINK Management Software (Version 10)

FDA UDI

Class I (US FDA UDI)

by Biometrics Limited

Identity

Trade Name: DataLINK Management Software (Version 10) FDA UDI
Generic Name: Bio-energy mapping system application software FDA UDI
Device Name: The DataLINK Management Software allows the user to set up the DataLINK communications with the computer, configure the sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming data to third party software. Software is available in English, Chinese, and Japanese. FDA UDI
Model / Reference: 310xx-00 FDA UDI
Description: The DataLINK Management Software allows the user to set up the DataLINK communications with the computer, configure the sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming data to third party software. Software is available in English, Chinese, and Japanese. FDA UDI

Identifiers

Primary DI / UDI-DI: 05060481691932 FDA UDI
FDA Product Code: KQX FDA UDI
IKK FDA UDI
GMDN Term: Bio-energy mapping system application software FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.1500 FDA UDI
890.1925 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

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Expiration Date

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Manufacturing Date

FDA UDI

Category: Bio-energy mapping system application software

DataLINK Management Software (Version 10) by Biometrics Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bio-energy mapping system application software.

DataLINK Management + Analysis Software (Version 10) — BIOMETRICS LIMITED · Class II

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 cb20fa30-d508-40d1-af93-e4098b4d3b0a 33 fields · synced May 30, 2026