H03
by TOOsonix A/S Denmark EUDAMED
Ref H03 - 0.8 mm, H03 - 2.3 mm, H03 - 1.8 mm, H03-1.3 mmModel S02
EMDN V9011
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number57000021926SysONE-MRZ | Date10 Apr 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- System ONE-M
- Model / Reference
- S02, H03 - 0.8 mm, H03 - 2.3 mm, H03 - 1.8 mm, H03-1.3 mm
- Primary DI / UDI-DI
- 05700002192615, 05700002192646, 05700002192639, 05700002192622
- Basic UDI-DI
- 57000021926SysONE-MRZ
- Direct Marketing DI
- 05700002192615057000021926460570000219263905700002192622
- EMDN Code
- V9011 Multifunctional transducers
- Device Class
- Class IIa
- Market of Registration
- Denmark
Manufacturer details
- EUDAMED SRN
- DK-MF-000014211
Other devices from TOOsonix A/S
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 (4)
- EUDAMED 9974664c-75d2-4df7-9620-bf15ba93e3d6
- EUDAMED 05700002192646|57000021926SYSONE-MRZ
- EUDAMED 05700002192639|57000021926SYSONE-MRZ
- EUDAMED 05700002192622|57000021926SYSONE-MRZ