Identity
- Trade Name
- LE230 series DataLITE Wireless EMG sensors EUDAMED
- Device Name
- Data Acquisition Products EUDAMED
- Model / Reference
- LE230 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060481692175 EUDAMED
- Basic UDI-DI
- 506048169DataAcqProdAD EUDAMED
- EMDN Code
- N010101 ELECTROMYOGRAPHIC ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
LE230 series DataLITE Wireless EMG sensors by Biometrics Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506048169DataAcqProdAD | Class I | Active |
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Manufacturer
- Manufacturer
- Biometrics Ltd
- EUDAMED SRN
- GB-MF-000002774
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED bea46cf8-9b32-48f5-84c9-6ab9597e7daf 61 fields · synced Jun 19, 2026