Orifice Medical AB
SwedenFDA applicant, unverified
- Devices
- 2
What Orifice Medical AB makes
Orifice Medical AB manufactures endoscope cleaning brushes, including the ORIBRUSH with a protective tip and a standard ORIBRUSH, designed for cleaning and maintaining medical endoscopes.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
Oribrush - With Protective Tip - B001 Ref K991595
Regimes: 510(k) Registry: 510(k)Oribrush - Standard - B002 Ref K991593
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Orifice Medical AB have in the registry?
The registry currently lists 2 devices for Orifice Medical AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orifice Medical AB's devices?
Among its 2 most recently registered devices, Orifice Medical AB has devices listed in FDA 510(k) (2 devices).
What risk classes do Orifice Medical AB's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Orifice Medical AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orifice Medical AB in the registry?
The most recently registered devices listed for Orifice Medical AB include ORIBRUSH - WITH PROTECTIVE TIP - B001 and ORIBRUSH - STANDARD - B002.