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Biometrics Ltd Analysis Software

EUDAMEDFDA UDI

Class I (EU MDR)

Ref DataLITE Management + Analysis Software (version 10)Ref Vx

by Biometrics Ltd

Identity

Trade Name
Biometrics Ltd Analysis Software EUDAMED
Biometrics Ltd DataLITE Analysis Software EUDAMED
DataLITE Management + Analysis Software (Version 10) FDA UDI
Generic Name
Bio-energy mapping system application software FDA UDI
Device Name
Data Acquisition Products EUDAMED
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 DataLITE Management Software allows the user to set up the DataLITE communications with the computer, configure the DataLITE 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
DataLITE Management + Analysis Software (version 10) EUDAMED
Vx EUDAMED
510xx-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 DataLITE Management Software allows the user to set up the DataLITE communications with the computer, configure the DataLITE 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
05060481690867 EUDAMEDFDA UDI
05060481690959 EUDAMED
Basic UDI-DI
506048169DataAcqProdAD EUDAMED
FDA Product Code
HCC FDA UDI
IKK FDA UDI
KQX FDA UDI
EMDN Code
Z12069092 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Z12040192 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
GMDN Term
Bio-energy mapping system application software FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
882.5050 FDA UDI
890.1925 FDA UDI
888.1500 FDA UDI
Market of Registration
Northern Ireland EUDAMED
Malta EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Biometrics Ltd Analysis Software by Biometrics Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biometrics Ltd
EUDAMED SRN
GB-MF-000002774
Authorised Representative
Advena Limited MT-AR-000000234

Sources (3)

  • EUDAMED 542bff3b-f21e-445c-8bca-d7127d74b0bd 61 fields · synced Jul 27, 2026
  • FDA UDI 97bd6cb8-8940-4f4b-bbde-58e72b804664 33 fields · synced May 30, 2026
  • EUDAMED 610002a8-9be2-44b9-bffe-c8682e652949 61 fields · synced Jul 27, 2026