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Aerosol Masks
EUDAMEDClass IIa (EU MDR)
Ref 6972091922643Model Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant
Identity
- Trade Name
- Aerosol Masks EUDAMED
- Device Name
- Nebulizer with Aerosol Masks EUDAMED
- Model / Reference
- Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant EUDAMED6972091922643 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972091922643 EUDAMED
- Basic UDI-DI
- 697209192ASM02GD EUDAMED
- Direct Marketing DI
- 06972091922643 EUDAMED
- EMDN Code
- R03010301 AEROSOL THERAPY MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Aerosol Masks by Bonree Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697209192ASM02GD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bonree Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000017844
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 4b7e7ae6-5fcc-4f9a-bf9a-8851d202b605 61 fields · synced Jun 17, 2026