Distriflor S.A.
Country not established
- Devices
- 1
What Distriflor S.A. makes
Distriflor S.A. manufactures the ASEPTYLUM, a UNI-CARRIER device designed for controlled transport and containment of sterile medical items or supplies, ensuring aseptic conditions during transit.
The company’s portfolio is regulated under FDA’s Class I medical devices and requires 510(k) clearance. The devices are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Aseptylum, Uni-Carrier Ref K961714
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Distriflor S.A. have in the registry?
The registry currently lists 1 device for Distriflor S.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Distriflor S.A.'s devices?
Among its 1 most recently registered device, Distriflor S.A. has devices listed in FDA 510(k) (1 device).
What risk classes do Distriflor S.A.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Distriflor S.A.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Distriflor S.A. in the registry?
The most recently registered devices listed for Distriflor S.A. include ASEPTYLUM, UNI-CARRIER.