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Biometrics Ltd Management Software
EUDAMEDFDA UDIClass I (EU MDR)
Ref DataLITE Management Software (version 10)Ref Vx
Identity
- Trade Name
- Biometrics Ltd Management Software EUDAMEDBiometrics Ltd DataLITE Management Software EUDAMEDDataLITE Management Software (Version 10) FDA UDI
- Generic Name
- Bio-energy mapping system application software FDA UDI
- Device Name
- Data Acquisition Products EUDAMEDThe 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 to third party software. Software is available in English, Chinese, and Japanese. FDA UDI
- Model / Reference
- DataLITE Management Software (version 10) EUDAMEDVx EUDAMED510xx-100 FDA UDI
- Description
- 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 to third party software. Software is available in English, Chinese, and Japanese. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060481690850 EUDAMEDFDA UDI05060481690942 EUDAMED
- Basic UDI-DI
- 506048169DataAcqProdAD EUDAMED
- FDA Product Code
- KQX FDA UDIIKK FDA UDIHCC FDA UDI
- EMDN Code
- Z12069092 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMEDZ12040192 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 EUDAMEDFDA UDI
- Regulation Number
- 888.1500 FDA UDI890.1925 FDA UDI882.5050 FDA UDI
- Market of Registration
- Northern Ireland EUDAMEDMalta 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 Management 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506048169DataAcqProdAD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biometrics Ltd
- EUDAMED SRN
- GB-MF-000002774
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED 9a6db1c1-d01f-4f68-ba10-831969c462b0 61 fields · synced Jul 16, 2026
- FDA UDI a0ce0938-495b-4edc-a3de-3031435e151a 33 fields · synced May 29, 2026
- EUDAMED 01bf8d39-2cfc-488f-b172-5ea6608bfe10 61 fields · synced Jul 13, 2026