Identity
- Model / Reference
- RF9-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08018294015503 EUDAMED
- Basic UDI-DI
- 8018294RF9-1SY EUDAMED
- EMDN Code
- R03010380 AEROSOL THERAPY SYSTEMS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Rf9-1 by FLAEM NUOVA SpA — 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 | 8018294RF9-1SY | Class IIa | Active |
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Manufacturer
- Manufacturer
- FLAEM NUOVA SpA
- EUDAMED SRN
- IT-MF-000007769
Sources (1)
- EUDAMED c23c1cc2-164c-4174-8ffc-6460927a7fe4 61 fields · synced Jun 19, 2026