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Aerogen Solo Nebuliser (25 Pack)
EUDAMEDClass IIb (EU MDR)
Ref AG-AS3600Model AG-AS3100
by Aerogen Ltd
Identity
- Trade Name
- Aerogen Solo Nebuliser (25 Pack) EUDAMED
- Device Name
- Aerogen Solo Nebuliser (5 Pack) EUDAMEDAerogen Solo Nebuliser EUDAMED
- Model / Reference
- AG-AS3100 EUDAMEDAG-AS3600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391517937862 EUDAMED
- Basic UDI-DI
- 539151793AG00009WS EUDAMED
- Unit of Use DI
- 05391517936858 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria 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
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Aerogen Solo Nebuliser (25 Pack) by Aerogen Ltd — Class IIb — 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 | 539151793AG00009WS | Class IIb | Active |
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Manufacturer
- Manufacturer
- Aerogen Ltd
- EUDAMED SRN
- IE-MF-000004597
Sources (2)
- EUDAMED 8f9aad4a-054c-4137-af56-eebcec05afc9 61 fields · synced Jun 18, 2026
- EUDAMED 9e69ffb1-dc61-49bf-ae66-1089c90ddfe8 61 fields · synced Jun 18, 2026