Sapimed S.p.A.
Country not established
Part of SAPI MED S.p.A.
- Devices
- 3
What Sapimed S.p.A. makes
Sapimed S.P.A. manufactures disposable endoscopy tools, including self-light anoscope scopes for rectal examinations and disposable sigmoidoscopes for lower gastrointestinal inspections. The company also produces the LEM Hemorrhoidal Ligator (Models A.5650 and A.5660), a device used for hemorrhoid treatment via band ligation.
These products fall under FDA Class II regulation and are recorded in the 510(k) clearance database. The company is based in the United States.
Catalogue
Self-Light Disposable Anoscope Ref K070913
Regimes: CE MDR 510(k) Registry: 510(k)Sapimed Disposable Sigmoidoscope Ref K070915
Regimes: 510(k) Registry: 510(k)Lem Hemorrhoidal Ligator, Models A.5650, A.5660 Ref K070881
Regimes: CE MDR CE MDD 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sapimed S.P.A. have in the registry?
The registry currently lists 3 devices for Sapimed S.P.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sapimed S.P.A.'s devices?
Among its 3 most recently registered devices, Sapimed S.P.A. has devices listed in FDA 510(k) (3 devices).
What risk classes do Sapimed S.P.A.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Sapimed S.P.A.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sapimed S.P.A. in the registry?
The most recently registered devices listed for Sapimed S.P.A. include SELF-LIGHT DISPOSABLE ANOSCOPE, SAPIMED DISPOSABLE SIGMOIDOSCOPE and LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660.