DataLINK Management + Analysis Software (Version 10)

FDA UDI

Class II (US FDA UDI)

by Biometrics Limited

Identity

Trade Name: DataLINK Management + Analysis Software (Version 10) FDA UDI
Generic Name: Bio-energy mapping system application software FDA UDI
Device Name: The Biometrics Analysis Software is a comprehensive tool for EMG, Goniometer and associated sensor analysis including real-time data analysis as the data is collected. The Analysis software also contains all of the features of the Management Software: 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 Software is available in English, Chinese, and Japanese. FDA UDI
Model / Reference: 310xx-11 FDA UDI
Description: The Biometrics Analysis Software is a comprehensive tool for EMG, Goniometer and associated sensor analysis including real-time data analysis as the data is collected. The Analysis software also contains all of the features of the Management Software: 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 Software is available in English, Chinese, and Japanese. FDA UDI

Identifiers

Primary DI / UDI-DI: 05060481691949 FDA UDI
FDA Product Code: IKK FDA UDI
KQX FDA UDI
GMDN Term: Bio-energy mapping system application software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.1925 FDA UDI
888.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

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Implantable

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Contains Latex

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Prescription Use

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

Yes

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Lot / Batch Number

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Serial Number

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Expiration Date

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Manufacturing Date

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Category: Bio-energy mapping system application software

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

Similar devices

Also classified as Bio-energy mapping system application software.

DataLINK Management Software (Version 10) — BIOMETRICS LIMITED · Class I

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 67e8ab21-97e7-4a33-af0b-df391a324d73 33 fields · synced Jun 8, 2026