Identity
- Trade Name
- FREELY EUDAMED
- Device Name
- MESH NEBULIZER EUDAMED
- Model / Reference
- UN300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973893300196 EUDAMED
- Basic UDI-DI
- B-06973893300196 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Freely 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-06973893300196 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Nile Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000034225
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 7b9df507-a22e-4bfa-8dd0-c424ae2d41a7 61 fields · synced Jun 18, 2026