Identity
- Trade Name
- AERO COMFORT EUDAMED
- Device Name
- NEBULIZER: Mask / Mouth Piece with Nebulization Chamber and Tubing. EUDAMED
- Model / Reference
- SH-2403S KAD EUDAMEDSH-2403S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265011180 EUDAMED08907265240337 EUDAMED08907265240344 EUDAMED
- Basic UDI-DI
- 8907265B019YV EUDAMED
- EMDN Code
- R03010304 AEROSOL THERAPY KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Aero Comfort by Romsons Group Private Limited — 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 | 8907265B019YV | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Romsons Group Private Limited
- EUDAMED SRN
- IN-MF-000036506
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 5b34773a-e23c-46bc-bb78-c73abd401e3c 61 fields · synced Jul 28, 2026
- EUDAMED d8cf2227-97bc-4988-983b-82638faea0c6 61 fields · synced May 19, 2026
- EUDAMED b5908efd-470d-46eb-bdbb-954352e2ca1c 61 fields · synced Jul 28, 2026