Identity
- Trade Name
- AEROTEK EUDAMED
- Device Name
- NEBULIZER: Mask / Mouth Piece with Nebulization Chamber and Tubing. EUDAMED
- Model / Reference
- SH-2426S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265242607 EUDAMED08907265242614 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
Aerotek 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 (2)
- EUDAMED 7a91526e-c59c-448e-9d9c-7d55f636ad19 61 fields · synced Sep 18, 2026
- EUDAMED afc9c3d1-aca8-42a0-9cf5-fd75fb9a5344 61 fields · synced May 17, 2026