Assut Europe S.p.A.
Country not established FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Assut Europe S.p.A. makes
Assut Europe S.P.A. manufactures permanent sutures, including the ASSUFIL line and Assut Filbloc, designed for surgical applications requiring long-term tissue fixation.
These products fall under FDA Class II and are listed via 510(k) clearance. The company operates from the US, adhering to US regulatory requirements for medical devices.
Catalogue
Assufil Ref K021767
Regimes: 510(k) Registry: 510(k)Assut Filbloc Permanent Sutures Ref K171039
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Assut Europe S.P.A. Magliano Dei Marsi L'Aquila · IT FEI 3003272809
Frequently asked questions
How many devices does Assut Europe S.P.A. have in the registry?
The registry currently lists 2 devices for Assut Europe S.P.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Assut Europe S.P.A.'s devices?
Among its 2 most recently registered devices, Assut Europe S.P.A. has devices listed in FDA 510(k) (2 devices).
What risk classes do Assut Europe S.P.A.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Assut Europe S.P.A.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Assut Europe S.P.A. in the registry?
The most recently registered devices listed for Assut Europe S.P.A. include ASSUFIL and Assut Filbloc Permanent Sutures.
Which FDA establishments are linked to Assut Europe S.P.A.?
1 FDA establishment is linked to Assut Europe S.P.A. in the registry; they are listed on the company page.