S.A.L.F. Spa
ItalyFDA 510(k) applicant, unverified
- Devices
- 6
What S.A.L.F. Spa makes
S.A.L.F. Spa manufactures sterile, single-use solutions for peritoneal dialysis, including variations such as the Servator M, Servator P with THAM, Servator B, Servator C, and Servator P Plus formulations. The company also produces PVC-free peritoneal dialysis solutions in 1000 ml and 2000 ml bags under the Servator H series.
These peritoneal dialysis solutions are classified as Class II medical devices and are listed under the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Servator M SALF Solution Ref K211842
CE MDR 510(k) 510(k)Servator P SALF Solution with THAM Ref K202652
CE MDR 510(k) 510(k)Servator B SALF Solution Ref K180481
CE MDR 510(k) 510(k)Servator C SALF Solution Ref K190063
CE MDR 510(k) 510(k)Servator P Plus SALF Solution Ref K230193
CE MDR 510(k) 510(k)Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags Ref K170150
CE MDR 510(k) 510(k)
Frequently asked questions
How many devices does S.A.L.F. Spa have in the registry?
The registry currently lists 6 devices for S.A.L.F. Spa. Devices recorded under merged duplicate company entries are counted once.
Which registries list S.A.L.F. Spa's devices?
Among its 6 most recently registered devices, S.A.L.F. Spa has devices listed in FDA 510(k) (6 devices).
What risk classes do S.A.L.F. Spa's devices fall under?
Among its 6 most recently registered devices, the classes recorded for S.A.L.F. Spa's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from S.A.L.F. Spa in the registry?
The most recently registered devices listed for S.A.L.F. Spa include Servator M SALF Solution, Servator P SALF Solution with THAM, Servator B SALF Solution and Servator C SALF Solution.