DataLITE LE230 Wireless EMG Sensor
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- LE230 series DataLITE Wireless EMG sensors EUDAMEDDataLITE LE230 Wireless EMG Sensor FDA UDI
- Generic Name
- Electromyography telemetric monitoring system transmitter FDA UDI
- Device Name
- Data Acquisition Products EUDAMEDThe DataLITE wireless surface EMG sensor gives superb quality of signal and ease of use. With a bandwidth of 5-495 Hz and a built in 1000 gain amplifier and wireless transmitter, surface EMG signals are collected and sent to the Biometrics software for analysis. EMG data can be synchronized real-time with other sensors as part of a complete DataLITE system.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 FDA UDI
- Model / Reference
- LE230 EUDAMEDFDA UDI
- Description
- The DataLITE wireless surface EMG sensor gives superb quality of signal and ease of use. With a bandwidth of 5-495 Hz and a built in 1000 gain amplifier and wireless transmitter, surface EMG signals are collected and sent to the Biometrics software for analysis. EMG data can be synchronized real-time with other sensors as part of a complete DataLITE system.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060481690638 EUDAMEDFDA UDI
- Basic UDI-DI
- 506048169DataAcqProdAD EUDAMED
- FDA Product Code
- HCC FDA UDI
- EMDN Code
- N010101 ELECTROMYOGRAPHIC ELECTRODES EUDAMED
- GMDN Term
- Electromyography telemetric monitoring system transmitter FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5050 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Electromyography telemetric monitoring system transmitter
DataLITE LE230 Wireless EMG Sensor by Biometrics Limited — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biometrics Limited
Sources (2)
- FDA UDI 7fced320-417b-4153-a702-7d4fabacbbcf 33 fields · synced Jul 26, 2026
- EUDAMED 12a614bf-cceb-44bd-9b04-7158d7ba9c69 61 fields · synced Jul 26, 2026