Identity
- Device Name
- Compressor nebulizer EUDAMED
- Model / Reference
- BR-CN116 EUDAMEDBR-CN195 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070911959 EUDAMED
- Basic UDI-DI
- 697507091CNZN EUDAMED
- Direct Marketing DI
- 06975070911959 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ShenZhen Bi-rich Medical Devices Co., Ltd
- EUDAMED SRN
- CN-MF-000023061
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 0b71281b-1308-48e9-8bf4-3478f21ed93f 61 fields · synced Jun 18, 2026