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Compressor nebulizer
EUDAMEDClass IIa (EU MDR)
Ref BR-CN188Model BR-CN116Ref BR-CN126Ref BR-CN143Ref BR-CN116Ref BR-CN003Ref BR-CN238
Identity
- Trade Name
- Prolife PN Basic EUDAMED
- Device Name
- Compressor nebulizer EUDAMED
- Model / Reference
- BR-CN116 EUDAMEDBR-CN188 EUDAMEDBR-CN126 EUDAMEDBR-CN143 EUDAMEDBR-CN003 EUDAMEDBR-CN238 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070911881 EUDAMED06975070911263 EUDAMED06975070911430 EUDAMED06975070911164 EUDAMED06975070910037 EUDAMED06975070916114 EUDAMED
- Basic UDI-DI
- 697507091CNZN EUDAMED
- Direct Marketing DI
- 06975070911263 EUDAMED06975070910037 EUDAMED06975070916114 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMEDSpain EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
No
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
Compressor nebulizer by ShenZhen Bi-rich Medical Devices 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 | 697507091CNZN | Class IIa | Active |
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Manufacturer
- Manufacturer
- ShenZhen Bi-rich Medical Devices Co., Ltd
- EUDAMED SRN
- CN-MF-000023061
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (7)
- EUDAMED 39bb805a-7c81-42e7-bff6-417aec9428b5 61 fields · synced Oct 6, 2026
- EUDAMED 5356f1a4-fddc-470b-8c46-d90812224c9d 61 fields · synced May 18, 2026
- EUDAMED 4a033a66-644f-45ef-9f3e-2165f531107b 61 fields · synced May 18, 2026
- EUDAMED dc32332d-e700-40f1-8929-7f82538aa6d5 61 fields · synced May 18, 2026
- EUDAMED e1d9b865-4006-4ba3-aecf-750f9c47cac1 61 fields · synced May 18, 2026
- EUDAMED 1d5e3814-650a-4872-9a44-849678f691ba 61 fields · synced May 19, 2026
- EUDAMED 433529f0-5e90-465d-b735-aee1141bf9b7 61 fields · synced Jul 12, 2026