BM Nebulizer with Aerosol Masks
by Bonree Medical Co., Ltd. 10 variants
Ref 10403001Model Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant. Nebulizer Jar: 6ml/8ml
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697209192ASM02GD 06972091922803 | Date8 May 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Nebulizer with Aerosol Masks
- Model / Reference
- Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant. Nebulizer Jar: 6ml/8ml, 10403001
- Primary DI / UDI-DI
- 06972091922803
- Basic UDI-DI
- 697209192ASM02GD
- Direct Marketing DI
- 06972091922803
- EMDN Code
- R03010301 Aerosol therapy masks
- Device Class
- Class IIa
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000017844
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Bonree Medical Co., Ltd.
Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No