Identity
- Trade Name
- ASSUFIL MONOFILAMENTO EUDAMED
- Device Name
- ASSUFIL MONOFILAMENTO EUDAMED
- Model / Reference
- FS570MAT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 38033439389722 EUDAMED
- Basic UDI-DI
- 8033439ASSUFILM-PDOUG EUDAMED
- Direct Marketing DI
- 38033439389722 EUDAMED
- EMDN Code
- H010101010101 POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY 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
Category: Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Assufil Monofilamento by Assut Europe Spa — Class III — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Polyester suture, bioabsorbable, monofilament, non-antimicrobial.
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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 | 8033439ASSUFILM-PDOUG | Class III | Active |
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Manufacturer
- Manufacturer
- Assut Europe Spa
- EUDAMED SRN
- IT-MF-000018178
Sources (1)
- EUDAMED eff54da0-3aa3-4e1a-8ab4-57ed4f94e633 61 fields · synced Oct 7, 2026