Ensi-Med International Pty., Ltd.
AustraliaFDA applicant, unverified
- Devices
- 1
What Ensi-Med International Pty., Ltd. makes
Ensi-Med International manufactures the E.N.S.I. Retractable Safety Syringe, a single-use syringe designed to retract the needle into the plunger after use to reduce needle-stick injuries.
The company’s product is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
E.N.S.I. Retractable Safety Syringe Ref K003348
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ensi-Med International Pty., Ltd. have in the registry?
The registry currently lists 1 device for Ensi-Med International Pty., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ensi-Med International Pty., Ltd.'s devices?
Among its 1 most recently registered device, Ensi-Med International Pty., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Ensi-Med International Pty., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Ensi-Med International Pty., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ensi-Med International Pty., Ltd. in the registry?
The most recently registered devices listed for Ensi-Med International Pty., Ltd. include E.N.S.I. RETRACTABLE SAFETY SYRINGE.