Identity
- Trade Name
- Aerogen Ultra-10 PK EUDAMED
- Device Name
- Aerogen Ultra EUDAMED
- Model / Reference
- AG-AS7000-EUR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391517937879 EUDAMED
- Basic UDI-DI
- 539151793AG00013WH EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Aerogen Ultra-10 PK by Aerogen Ltd — 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 | 539151793AG00013WH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Aerogen Ltd
- EUDAMED SRN
- IE-MF-000004597
Sources (1)
- EUDAMED 645c76fb-8191-4052-ae75-3ee7e2942ef2 61 fields · synced Jun 19, 2026