Identity
- Model / Reference
- P0915EM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08018294015800 EUDAMED
- Basic UDI-DI
- 8018294P0915EMB6 EUDAMED
- Direct Marketing DI
- 08018294015800 EUDAMED
- EMDN Code
- Z12159002 AEROSOL EQUIPMENT 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
P0915em 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 | 8018294P0915EMB6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- FLAEM NUOVA SpA
- EUDAMED SRN
- IT-MF-000007769
Sources (1)
- EUDAMED 14125cb6-42d8-4c55-a180-bc7bb370f009 61 fields · synced Sep 17, 2026