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Sign in to claim this brandASSUT EUROPE SPA
Italy·IT-MF-000018178
Last updated September 18, 2026
About
In Assut Europe we dedicate a continuous commitment to developing innovative products and solutions to improve patient life. For more than 30 years we have been working with all healthcare professionals to ensure technological and innovative solutions, adapting us to all needs to improve patient health.
Translated from the manufacturer's own website. Source
What ASSUT EUROPE SPA makes
The company manufactures bioabsorbable and non-bioabsorbable sutures, including polyester and polyolefin variants, with some featuring barbed designs for tissue fixation. Products include monofilament and multifilament sutures, both antimicrobial-free, as well as fluoropolymer-enhanced monofilament sutures for surgical applications.
These devices fall under EU Class II and Class III classifications, with listings in the EUDAMED registry and the FDA’s UDI system. The manufacturer is based in Italy.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does ASSUT Europe SPA primarily manufacture?
ASSUT Europe SPA specializes in surgical sutures, producing both bioabsorbable and non-bioabsorbable variants. Their portfolio includes polyester sutures (monofilament and multifilament, non-antimicrobial), barbed polyester sutures, barbed polyolefin sutures, and polyolefin/fluoropolymer monofilament sutures. These are designed for tissue approximation and fixation in surgical procedures, with variations tailored for specific clinical needs like faster absorption or enhanced handling.
Where is ASSUT Europe SPA based, and how does this affect its regulatory compliance?
ASSUT Europe SPA is headquartered in Italy, which means its devices must comply with EU Medical Device Regulations (MDR) or the Medical Device Directive (MDD) depending on the applicable timeline. The company’s products are listed in the EUDAMED registry, confirming their registration under EU requirements. Additionally, some devices are included in the FDA’s UDI system, indicating they are also marketed in the U.S. under FDA oversight.
Which regulatory registries list ASSUT Europe SPA’s devices, and why is this important?
ASSUT Europe SPA’s devices are listed in the EUDAMED registry (European database for medical devices) and the FDA’s UDI system (Unique Device Identifier). EUDAMED ensures transparency and traceability of devices under EU regulations, while the FDA’s UDI system provides a standardized way to identify medical devices in the U.S., improving patient safety and regulatory tracking. Listing in these systems confirms compliance with respective jurisdictions’ requirements.
How are ASSUT Europe SPA’s sutures classified under EU regulations, and what does this mean for their use?
ASSUT Europe SPA’s sutures are classified as EU Class II or Class III devices. Class II devices typically pose a moderate risk (e.g., sutures requiring special controls to ensure safety and performance), while Class III devices involve higher risks (e.g., those used in life-supporting or life-sustaining procedures). This classification determines the regulatory scrutiny, clinical evidence requirements, and post-market surveillance obligations the manufacturer must meet to ensure their devices remain safe and effective for surgical use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Italy
- Address
- 12, G. Gregoraci, Rome, Italy
- Website
- www.assuteurope.com
- [email protected]
- Phone
- +39 0863 515000
- PRRC Contact
- Viviana Di Cintio
- EUDAMED SRN
- IT-MF-000018178
- FDA FEI Number
- —
- DUNS Number
- 654747567
Catalogue (174)
Page 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Assufil Monofilamento | 5FV57MHBS3YSL | FDA UDI | Class II | Active |
| Filbloc Permanent | PS920 | FDA UDI | Class II | Active |
| Assufil Monofilamento | 10F.L./R/C/18/W/4 | FDA UDI | Class II | Active |
| Assufil Monofilamento | 06F.L.12DN/10 | FDA UDI | Class II | Active |
| Assufil Monofilamento | 5FV60MH4YSO | FDA UDI | Class II | Active |
| Assufil | FW515 | FDA UDI | Class II | Active |
| Assufil | FR424AT | FDA UDI | Class II | Active |
| Assufil Monofilamento | 5FW69MMYSI | FDA UDI | Class II | Active |
| Assufil | FW371WAP | FDA UDI | Class II | Active |
| Filbloc | FV373HHAA | FDA UDI | Class II | Active |
| Assufil Monofilamento | 5FW66MMYSG | FDA UDI | Class II | Active |
| Filbloc | FS77CHHAA | FDA UDI | Class II | Active |
| Filbloc | FU38EHHAH | FDA UDI | Class II | Active |
| Assufil Monofilamento | 06F.L.23DN/10 | FDA UDI | Class II | Active |
| Assufil Monofilamento | 5FV57MHYAB | FDA UDI | Class II | Active |
| Filbloc | FQ478HHAH | FDA UDI | Class II | Active |
| Assufil Monofilamento | 06F.L12 | FDA UDI | Class II | Active |
| Assufil Monofilamento | 5FY58MMYSL | FDA UDI | Class II | Active |
| E-Loc Non-Absorbable Endo 360° Barbed Suture | ECN-NABAR20 | FDA UDI | Class II | Active |
| Filbloc Permanent | PZ890 | FDA UDI | Class II | Active |
| Assufil Monofilamento | 10F.L./R/C/15/4 | FDA UDI | Class II | Active |
| Assufil Monofilamento | 06F.L.23DN/0/18 | FDA UDI | Class II | Active |
| Assufil Monofilamento | 5FY58MMYSI | FDA UDI | Class II | Active |
| Assufil Monofilamento | 5FV60MHB1YSL | FDA UDI | Class II | Active |
| Assufil Monofilamento | 06F.L.12DN/7/S/C | FDA UDI | Class II | Active |
| Assufil Monofilamento | 5FV57MHBS3YSL | FDA UDI | Class II | Active |
| Assufil Monofilamento | 06F.L.12DN/2/0W/10 | FDA UDI | Class II | Active |
| Filbloc | FV373HHAB | FDA UDI | Class II | Active |
| Assufil Monofilamento | 5FS65MHYSO | FDA UDI | Class II | Active |
| Filbloc | FS028HHAC | FDA UDI | Class II | Active |
| Filbloc Permanent | PLY-G02-020-APL | FDA UDI | Class II | Active |
| E-Loc Endo 360° Barbed Suture | ECN-BAR20 | FDA UDI | Class II | Active |
| Assufil Monofilamento | 10F.L./R/C/15/W/4 | FDA UDI | Class II | Active |
| Assufil | FS464 | FDA UDI | Class II | Active |
| Filbloc Permanent | PS028HHAC | FDA UDI | Class II | Active |
| Filbloc | FS248HHAD/3 | FDA UDI | Class II | Active |
| Filbloc | FS412HHAH | FDA UDI | Class II | Active |
| Assufil Monofilamento | 06F.L.12DN/6 | FDA UDI | Class II | Active |
| Assufil | FS414WAT | FDA UDI | Class II | Active |
| Assufil | FV533 | FDA UDI | Class II | Active |
| Assufil Monofilamento | 5FW69MMYSL | FDA UDI | Class II | Active |
| Assufil | FR465 | FDA UDI | Class II | Active |
| Assufil Monofilamento | 06F.L.23DN/15 | FDA UDI | Class II | Active |
| Assufil Monofilamento | 5FV60MH2YSL | FDA UDI | Class II | Active |
| Assufil Monofilamento | 5FV60MHYSO | FDA UDI | Class II | Active |
| Assufil Monofilamento | FU534M | FDA UDI | Class II | Active |
| Assufil Monofilamento | 06F.L.23DN/2/0/18 | FDA UDI | Class II | Active |
| Assufil | FR855 | FDA UDI | Class II | Active |
| Filbloc Permanent | PLY-G02-020-A | EUDAMEDFDA UDI | Class II | Active |
| Assufil Monofilamento | 5FV60MHBD4YSO | FDA UDI | Class II | Active |
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