Aerosol therapy kit
Part of a family of 25 devices: see the family page
Ref \Model Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant. Nebulizer Jar: 6ml/8ml
Aerosol therapy kit (\) is a Class IIa device made by Bonree Medical Co., Ltd., registered in EUDAMED on 8 May 2023 (Basic UDI-DI 697209192ASM02GD), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697209192ASM02GD 06942382601632 | Date8 May 2023 | StatusActive |
Official records
- EUDAMED public site 697209192ASM02GD
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- Withdrawn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, \
- Primary DI / UDI-DI
- 06942382601632
- Basic UDI-DI
- 697209192ASM02GD
- Direct marketing DI
- 06942382601632
- EMDN code
- R060101 Cold nebulisation systems
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000017844
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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