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Aerogen Ultra (10 Pack)
EUDAMEDClass IIa (EU MDR)
Ref AG-AS7000-EU
by Aerogen Ltd
Identity
- Trade Name
- Aerogen Ultra (10 Pack) EUDAMED
- Model / Reference
- AG-AS7000-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391517930573 EUDAMED
- Basic UDI-DI
- B-05391517930573 EUDAMED
- EMDN Code
- R0699 NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Aerogen Ultra (10 Pack) by Aerogen Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05391517930573 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Aerogen Ltd
- EUDAMED SRN
- IE-MF-000004597
Sources (1)
- EUDAMED 627ada37-218d-48f9-86ab-b0e73f964353 61 fields · synced Jul 16, 2026