Identity
- Trade Name
- PEMPA EUDAMED
- Device Name
- Compressor nebulizer EUDAMED
- Model / Reference
- BR-CN116 EUDAMEDBR-CN195 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070916329 EUDAMED
- Basic UDI-DI
- 697507091CNZN EUDAMED
- Direct Marketing DI
- 06975070916329 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Pempa 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 (1)
- EUDAMED 507134c9-be99-468b-8c3d-b7caf148f8d3 61 fields · synced Oct 6, 2026