← Back to catalogue
Medocare Nebulizer Mask
EUDAMEDClass IIa (EU MDR)
Ref 10501001Model Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant. Nebulizer Jar: 6ml/8ml
Identity
- Trade Name
- Medocare Nebulizer Mask EUDAMED
- Device Name
- Nebulizer with Aerosol Masks EUDAMED
- Model / Reference
- Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant. Nebulizer Jar: 6ml/8ml EUDAMED10501001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942382602486 EUDAMED
- Basic UDI-DI
- 697209192ASM02GD EUDAMED
- Direct Marketing DI
- 06942382602486 EUDAMED
- EMDN Code
- R03010301 AEROSOL THERAPY MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Medocare Nebulizer Mask 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 |
Is this your device? Claim it to add documentation and request validation.
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 3f105e84-daac-4053-86bf-e9e165461b9d 61 fields · synced Jun 18, 2026