Unimar, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Unimar, Inc. makes
Unimar, Inc. manufactures diagnostic and interventional devices for gynecological and reproductive health procedures, including reinforcing styletttes, disposable hysteroscopy (HSG) trays, endometrial sampling tools like the Uni-Sem™ and Pippelle, and endocervical aspirators. Their portfolio also includes cervical brushes, manipulators like the Kronner Manipujector, and flexible catheters such as the Hui Mini-Flex.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company’s products are listed in the FDA’s 510(k) database, reflecting their regulatory compliance in the United States.
Catalogue
Kronner Reinforcing Stylette Ref K932432
Regimes: 510(k) Registry: 510(k)Sterile/Disposable Hsg Tray Ref K810291
Regimes: 510(k) Registry: 510(k)Uni-Sem(Tm) Ref K910317
Regimes: 510(k) Registry: 510(k)Endometrial Pipelle Ref K854415
Regimes: 510(k) Registry: 510(k)Kronner Manipujector Ref K904473
Regimes: 510(k) Registry: 510(k)Hui Mini-Flex Ref K895659
Regimes: 510(k) Registry: 510(k)Aspirette Endocervical Aspirator Ref K895403
Regimes: 510(k) Registry: 510(k)Hsg Tray Ref K920803
Regimes: 510(k) Registry: 510(k)Cervex-Brush Ref K890848
Regimes: 510(k) Registry: 510(k)Kdf-2.3 Ref K894264
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Unimar, Inc. have in the registry?
The registry currently lists 10 devices for Unimar, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Unimar, Inc.'s devices?
Among its 10 most recently registered devices, Unimar, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Unimar, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Unimar, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Unimar, Inc. in the registry?
The most recently registered devices listed for Unimar, Inc. include KRONNER REINFORCING STYLETTE, STERILE/DISPOSABLE HSG TRAY, UNI-SEM(TM) and ENDOMETRIAL PIPELLE.