Otoscope
by Soundlink Co., Ltd China EUDAMED
Ref SOT100Model SOT100 Or Customized.
EMDN Z12149099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697747389OtoscopeTB | Date23 Dec 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Otoscope
- Model / Reference
- SOT100 Or Customized., SOT100
- Primary DI / UDI-DI
- 06977473890008
- Basic UDI-DI
- 697747389OtoscopeTB
- EMDN Code
- Z12149099 Various ENT instruments - other
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000043038
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Soundlink Co., Ltd
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 1094af7a-4c1c-4d66-a4a9-7e88b4633029