Identity
- Trade Name
- b-good EUDAMED
- Device Name
- Mesh Nebulizer EUDAMED
- Model / Reference
- UN101 EUDAMEDUN101-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973893300042 EUDAMED
- Basic UDI-DI
- B-06973893300042 EUDAMED
- EMDN Code
- Z12040210 ULTRASONIC NEBULISERS 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
b-good by Shenzhen Nile Biotechnology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06973893300042 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Nile Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000034225
- Authorised Representative
- Share Info Consultant Service LLC Repräsentanzbüro DE-AR-000005133
Sources (1)
- EUDAMED c4e75e13-327b-4580-9705-d5d47d1315bc 61 fields · synced Oct 6, 2026