Stedim, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Stedim, Inc. makes
Stedim, Inc. manufactures sterile, single-use containers and compounding accessories for intravenous nutrition and medication preparation, including 3-liter total parenteral nutrition (TPN) bags and adaptors for automated compounding systems like the AUTOMIX.
These products are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Dual Compartment Tpn Bag 3 Liter Ref K911567
Regimes: 510(k) Registry: 510(k)Automix Compounder Y - Adaptor Set Ref K890205
Regimes: 510(k) Registry: 510(k)Automix Compounder Vented Spike Adaptor Ref K890204
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Stedim, Inc. have in the registry?
The registry currently lists 3 devices for Stedim, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stedim, Inc.'s devices?
Among its 3 most recently registered devices, Stedim, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Stedim, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Stedim, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Stedim, Inc. in the registry?
The most recently registered devices listed for Stedim, Inc. include DUAL COMPARTMENT TPN BAG 3 LITER, AUTOMIX COMPOUNDER Y - ADAPTOR SET and AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR.