Identity
- Trade Name
- MONOFIL EUDAMED
- Device Name
- MONOFIL EUDAMED
- Model / Reference
- FX374FW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 38033439446302 EUDAMED
- Basic UDI-DI
- 8033439MONOFIL3T EUDAMED
- Direct Marketing DI
- 38033439446302 EUDAMED
- EMDN Code
- H010101010301 POLIGLECAPRONE AND DERIVATIVES MONOFILAMENT WITH NEEDLE EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Monofil by Assut Europe Spa — Class III — 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 | 8033439MONOFIL3T | Class III | Active |
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Manufacturer
- Manufacturer
- Assut Europe Spa
- EUDAMED SRN
- IT-MF-000018178
Sources (1)
- EUDAMED bbc5cfd7-c706-45a8-9864-bca563e433e9 61 fields · synced Aug 1, 2026