Identity
- Trade Name
- AERO COMFORT EUDAMED
- Device Name
- NEBULISER: Mask / Mouth Piece with Nebulization Chamber and Tubing EUDAMED
- Model / Reference
- GS-2403 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120240323 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
EUDAMED
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 (1)
- EUDAMED de3b54ef-b39b-4f90-84fe-ff96c537973b 61 fields · synced Jun 19, 2026