Oxygen Mask
by Well Lead Medical Co., Ltd. China EUDAMED
Ref 222ECOModel Non-Rebreath Mask with oxygen tubing
EMDN R03010201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69449327FR01A00JT | Date15 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Non-Rebreath Mask with oxygen tubing, 222ECO
- Primary DI / UDI-DI
- 06936881187278
- Basic UDI-DI
- 69449327FR01A00JT
- EMDN Code
- R03010201 Air/oxygen masks
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000006728
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Well Lead Medical 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 06936881187278|69449327FR01A00JT