Identity
- Trade Name
- AIRROI EUDAMED
- Device Name
- MESH NEBULIZER EUDAMED
- Model / Reference
- UN101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973893300172 EUDAMED
- Basic UDI-DI
- B-06973893300172 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
Airroi 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-06973893300172 | 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 6fd20e1b-e847-4282-9980-60e5f78920e0 61 fields · synced Jun 18, 2026