Soundway
by Ningbo Shengyurui Medical Appliances Co., Ltd. 119 variants
Ref C0202Model Standard
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69450993NOCSTD01JD | Date26 Aug 2022 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Nasal Cannula
- Model / Reference
- Standard, C0202
- Primary DI / UDI-DI
- 06945099394088, 06945099394538, 06945099394491, 06945099394125
- Basic UDI-DI
- 69450993NOCSTD01JD
- Secondary DI
- 46945099394086, 46945099394536, 46945099394499, 46945099394123
- Direct Marketing DI
- 06945099394088069450993945380694509939449106945099394125
- EMDN Code
- R0301020301 Oxygen therapy standard nasal cannulas (goggles)
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000026643
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties
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