Identity
- Trade Name
- AERO COMFORT EUDAMED
- Device Name
- NEBULISER: Mask / Mouth Piece with Nebulization Chamber and Tubing EUDAMED
- Model / Reference
- GS-2403S EUDAMEDGS-2403 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120240361 EUDAMED08902120240347 EUDAMED08902120240354 EUDAMED08902120240330 EUDAMED08902120240316 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
Yes
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 Comfort 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Romsons International (Unit II)
- EUDAMED SRN
- IN-MF-000024594
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (5)
- EUDAMED 000e32c3-1f7b-451a-b9d1-30b8b0bcc907 61 fields · synced Jul 31, 2026
- EUDAMED 2620c37e-45a8-4ea3-8c51-09b803115d62 61 fields · synced May 18, 2026
- EUDAMED b1ce8542-7334-4dec-990e-ff4a6debae69 61 fields · synced May 19, 2026
- EUDAMED 32ef8bec-ba85-4950-9842-e3d3082b7e33 61 fields · synced May 19, 2026
- EUDAMED 41180e3c-76e8-47de-a389-b5e7a554b0eb 61 fields · synced May 19, 2026