Oxygen Concentrator Unit
by Atlas Copco (Wuxi) Compressor Co., Ltd. 8 variants
Ref BMO-300Model BMO series
Active
CE MDR
Valid until
4 Oct 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCN23/00005220 | Date16 Sep 2026 | StatusActive |
Certificates
- CN23/00005220 Active
Quality management system EU MDR
- Notified body
- SGS Belgium NV 1639
- Issued
- 16 Sep 2026
- Expires
- 4 Oct 2028
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- BMO series, BMO-300
- Primary DI / UDI-DI
- 06973607471921
- Basic UDI-DI
- 697360747OXY001UJ
- Direct Marketing DI
- 06973607471921
- EMDN Code
- Z120309 Medical/medicinal gas pipeline systems and related accessories
- Device Class
- Class IIb
- Market of Registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000026000
- Authorised representative
- Atlas Copco Airpower NV BE-AR-000024077
Other devices from Atlas Copco (Wuxi) Compressor Co., Ltd.
See all devices from Atlas Copco (Wuxi) Compressor Co., Ltd. →
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