Identity
- Trade Name
- AERO-MIST EUDAMED
- Device Name
- NEBULISER: Mask / Mouth Piece with Nebulization Chamber and Tubing EUDAMED
- Model / Reference
- GS-2074 EUDAMEDGS-2074S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120207425 EUDAMED08902120207449 EUDAMED08902120207432 EUDAMED08902120207418 EUDAMED
- Basic UDI-DI
- 8902120B019S2 EUDAMED
- EMDN Code
- R03010380 AEROSOL THERAPY SYSTEMS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Aero-Mist by Romsons International (Unit II) — 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 | 8902120B019S2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Romsons International (Unit II)
- EUDAMED SRN
- IN-MF-000024594
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED d6378910-150d-449f-888a-0cb6ed3f0c73 61 fields · synced Jul 29, 2026
- EUDAMED 0f2080fa-17f3-4a0f-8eb1-9d74a5c60f19 61 fields · synced May 11, 2026
- EUDAMED 36d2642a-3479-40d7-ad68-776dddebaef0 61 fields · synced May 16, 2026
- EUDAMED d815bcc5-f667-4d50-845d-453740de523e 61 fields · synced May 16, 2026