Identity
- Trade Name
- AERO MIST EUDAMED
- Device Name
- NEBULIZER: Mask / Mouth Piece with Nebulization Chamber and Tubing. EUDAMED
- Model / Reference
- SH-2074S EUDAMEDSH-2074S KAD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265207439 EUDAMED08907265207446 EUDAMED08907265207453 EUDAMED08907265011159 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 Mist 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 |
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Manufacturer
- Manufacturer
- Romsons Group Private Limited
- EUDAMED SRN
- IN-MF-000036506
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED 0773ba73-4b6d-4179-a9d0-73e67e2c7eba 61 fields · synced Aug 3, 2026
- EUDAMED 183587ca-5947-462d-856b-61a0cc6cb740 61 fields · synced May 18, 2026
- EUDAMED 90f7ce40-8dbc-4869-a7ed-777aa8382100 61 fields · synced May 19, 2026
- EUDAMED 83768b55-bf8a-4964-967a-7302560e6d7d 61 fields · synced May 19, 2026