Identity
- Trade Name
- SX230FW EMG Sensor (Gain 1000, Bandwidth 20-460Hz) - Plastic connector EUDAMEDSX230FW EMG Sensor FDA UDI
- Generic Name
- Electromyograph FDA UDI
- Device Name
- Data Acquisition Products EUDAMEDThe 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 BS EN 60601-1:2006 + A1:2013 SX230FW EMG Sensor (Gain 1000, Bandwidth 20-460Hz) - Plastic connector FDA UDI
- Model / Reference
- SX230FW EUDAMEDFDA 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 BS EN 60601-1:2006 + A1:2013 SX230FW EMG Sensor (Gain 1000, Bandwidth 20-460Hz) - Plastic connector FDA UDI
Identifiers
- Catalog Number
- bandwidth 20-460 plastic connector FDA UDI
- Primary DI / UDI-DI
- 05060481691468 EUDAMEDFDA UDI
- Basic UDI-DI
- 506048169DataAcqProdAD EUDAMED
- FDA Product Code
- HCC FDA UDI
- EMDN Code
- N010101 ELECTROMYOGRAPHIC ELECTRODES EUDAMED
- GMDN Term
- Electromyograph 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
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
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 — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 0a721a05-df9f-4cc3-b6e3-09f6d891b3cd 34 fields · synced Jul 10, 2026
- EUDAMED 0e00cc5f-009c-4681-9b67-6fd4d2b48a92 61 fields · synced Jul 10, 2026