Identity
- Trade Name
- SX230-1000 EMG Sensor (Gain 1000, Bandwidth 20-460Hz) - Plastic connector EUDAMEDSX230-1000 EMG Sensor FDA UDI
- Generic Name
- Electromyograph FDA UDI
- Device Name
- Data Acquisition Products EUDAMEDThe SX230-1000 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 SX230-1000 EMG Sensor (Gain 1000, Bandwidth 20-460Hz) - Plastic connector FDA UDI
- Model / Reference
- SX230-1000 EUDAMEDFDA UDI
- Description
- The SX230-1000 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 SX230-1000 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
- 05060481691420 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
SX230-1000 EMG Sensor by Biometrics Limited — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electromyograph.
- Sierra Wave — Cadwell Industries, Inc. · Class II
- NATUS NEUROLOGY — Natus Neurology Incorporated · Class II
- Natus — Xltek · Class II
- NATUS NEUROLOGY — Natus Neurology Incorporated · Class II
- NATUS NEUROLOGY — Natus Neurology Incorporated · Class II
- Cascade Elite — Cadwell Industries, Inc. · Class II
- Natus — Xltek · Class II
- Natus — Xltek · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biometrics Limited
Sources (2)
- FDA UDI e1f2c4c1-9e08-4d1f-acba-33a48faeb707 34 fields · synced Jun 18, 2026
- EUDAMED 056147bc-1c63-425b-9082-ef1b188a0244 61 fields · synced Jun 18, 2026