Umi, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Umi, Inc. makes
Umi, Inc. manufactures nephrostomy catheters for urinary drainage and two color video cameras (CRM-100 and CRM-114) designed for medical imaging procedures. Their product line also includes radiographic grids used in X-ray imaging to reduce scatter radiation.
The company’s devices are regulated under FDA classifications including Class I, Class II, and Unclassified (U), with submissions recorded in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
Nephrostomy Catheter Ref K823382
Regimes: 510(k) Registry: 510(k)Crm-100 Color Video Camera Ref K831412
Regimes: 510(k) Registry: 510(k)Grid/Radiographic Ref K883527
Regimes: 510(k) Registry: 510(k)Crm-114 Color Video Camera Ref K830924
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Umi, Inc. have in the registry?
The registry currently lists 4 devices for Umi, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Umi, Inc.'s devices?
Among its 4 most recently registered devices, Umi, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Umi, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Umi, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Umi, Inc. in the registry?
The most recently registered devices listed for Umi, Inc. include NEPHROSTOMY CATHETER, CRM-100 COLOR VIDEO CAMERA, GRID/RADIOGRAPHIC and CRM-114 COLOR VIDEO CAMERA.