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P0513em F1000 Ref 1
EUDAMEDClass IIa (EU MDR)
Ref P0513EM F1000 REF 1Model P0513EM F1000
Identity
- Model / Reference
- P0513EM F1000 EUDAMEDP0513EM F1000 REF 1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08018294016135 EUDAMED
- Basic UDI-DI
- 8018294P0513EM_F100022 EUDAMED
- Direct Marketing DI
- 08018294016135 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
P0513em F1000 Ref 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 | 8018294P0513EM_F100022 | Class IIa | Active |
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Manufacturer
- Manufacturer
- FLAEM NUOVA SpA
- EUDAMED SRN
- IT-MF-000007769
Sources (1)
- EUDAMED 364833da-23a9-40e6-a85f-ff39e84a27c1 61 fields · synced Jul 12, 2026