Tracheostomy mask
by Ningbo Shengyurui Medical Appliances Co., Ltd. China EUDAMED
Ref A0604-S6Model With tubing,Without tubing
EMDN R03010205
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69450993TMK001UQ | Date14 Oct 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- CN24/00007564 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 1639
- Issued
- 5 Oct 2026
- Expires
- 28 Nov 2029
- Reason
- Change approved
Specification
- Model / Reference
- With tubing, Without tubing, A0604-S6
- Primary DI / UDI-DI
- 06945099386984
- Basic UDI-DI
- 69450993TMK001UQ
- EMDN Code
- R03010205 Tracheostomy o2 suppliers
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000026643
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Ningbo Shengyurui Medical Appliances Co., Ltd.
See all devices from Ningbo Shengyurui Medical Appliances 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 06945099386984|69450993TMK001UQ