Identity
- Trade Name
- Soundway EUDAMED
- Device Name
- Nasal Cannula EUDAMED
- Model / Reference
- SoftPlus EUDAMEDC1216 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945099396808 EUDAMED
- Basic UDI-DI
- 69450993NOCSOS01KM EUDAMED
- Secondary DI
- 46945099396806 EUDAMED
- Direct Marketing DI
- 06945099396808 EUDAMED
- EMDN Code
- R0301020301 OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Soundway by Ningbo Shengyurui Medical Appliances Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69450993NOCSOS01KM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Shengyurui Medical Appliances Co., Ltd.
- EUDAMED SRN
- CN-MF-000026643
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 19da0297-9ab6-474b-9e9b-3a15d1fdf829 61 fields · synced Oct 6, 2026