Identity
- Trade Name
- SX230FW EMG Sensor FDA UDI
- Generic Name
- Electromyograph FDA UDI
- Device Name
- The SX230FW EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. The EMG Amplifier (SX230FW) uses disposable electrodes and has a variable electrode distance. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13. SX230FW EMG Sensor (Gain 1000, Bandwidth 20-460Hz) - Metal connector FDA UDI
- Model / Reference
- SX230FW FDA UDI
- Description
- The SX230FW EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. The EMG Amplifier (SX230FW) uses disposable electrodes and has a variable electrode distance. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13. SX230FW EMG Sensor (Gain 1000, Bandwidth 20-460Hz) - Metal connector FDA UDI
Identifiers
- Catalog Number
- bandwidth 20-460 metal connector FDA UDI
- Primary DI / UDI-DI
- 05060481691512 FDA UDI
- FDA Product Code
- HCC FDA UDI
- GMDN Term
- Electromyograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electromyograph
SX230FW EMG Sensor by Biometrics Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 1a805aae-e77d-4e19-9b32-85dbff197fc4 34 fields · synced May 30, 2026