Identity
- Trade Name
- AND EUDAMED
- Device Name
- Mesh nebulizer EUDAMED
- Model / Reference
- BR-MN199 EUDAMEDUN-303A-EC1B/BR-MN199 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070910426 EUDAMED
- Basic UDI-DI
- 697507091MN2P EUDAMED
- Direct Marketing DI
- 06975070910426 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
This medical device, AND, is a Class IIa approved and marketed product from ShenZhen Bi-rich Medical Devices Co., Ltd. It features a sterile container package with an ID of 06975070910426 and has undergone professional testing.
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 | 697507091MN2P | 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 5d942dec-134d-405b-b0cc-abf1f7239a12 61 fields · synced Oct 6, 2026