High Concentration Oxygen Mask
by Ningbo Shengyurui Medical Appliances Co., Ltd. China EUDAMED
Ref A0301-S5Model Non-rebreathing,Rebreathing,3 IN 1
EMDN R03010206
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCN24/00007564 | Date5 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
- Non-rebreathing, Rebreathing, 3 IN 1, A0301-S5
- Primary DI / UDI-DI
- 06945099392190
- Basic UDI-DI
- 69450993OMB001QQ
- EMDN Code
- R03010206 Masks with reservoir
- 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
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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 f9cc3c25-084e-4e09-aa97-76ad11f8f0e8