FOA03MM1305
by OT Bioelettronica srl Italy EUDAMED
Ref OT0371Model ADHESIVE FOAM
EMDN Z12100785
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805697785FOAMSHEET010KP | Date20 Apr 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- ADHESIVE FOAM, OT0371
- Primary DI / UDI-DI
- 08056977853004
- Basic UDI-DI
- 805697785FOAMSHEET010KP
- Direct Marketing DI
- 08056977853004
- EMDN Code
- Z12100785 EMG telemetry instruments - consumables
- 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 b2293ce5-a3e3-41e3-a887-158ef8ee7edd