GR04MM5407A
by OT Bioelettronica srl Italy EUDAMED
Ref OT0205Model ELECTRODES ARRAY
EMDN N010101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805697785ELECARRAY009C6 | Date20 Apr 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- ELECTRODES ARRAY, OT0205
- Primary DI / UDI-DI
- 08056977851598
- Basic UDI-DI
- 805697785ELECARRAY009C6
- Direct Marketing DI
- 08056977851598
- EMDN Code
- N010101 Electromyographic electrodes
- Device Class
- Class I
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000033348
Other devices from OT Bioelettronica srl
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: 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
Sources (1)
- EUDAMED 0810d7ad-4efb-476d-a8b5-b801909e2c69