Biop Medical, Ltd.
IsraelFDA applicant, unverified
- Devices
- 1
What Biop Medical, Ltd. makes
Biop Medical, Ltd. manufactures the Biop Digital Colposcope, a device used for examining the cervix, vagina, and vulva to detect abnormalities such as cervical cancer or precancerous changes. The colposcope provides magnified, high-resolution imaging to aid in diagnostic procedures.
The company’s portfolio is regulated under Class II medical devices in the United States, with the Biop Digital Colposcope authorised via the FDA’s 510(k) pathway. The device is listed in the FDA’s regulatory database, ensuring compliance with US medical device regulations.
Catalogue
Biop Digital Colposcope Ref K182764
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biop Medical, Ltd. have in the registry?
The registry currently lists 1 device for Biop Medical, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biop Medical, Ltd.'s devices?
Among its 1 most recently registered device, Biop Medical, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Biop Medical, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Biop Medical, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biop Medical, Ltd. in the registry?
The most recently registered devices listed for Biop Medical, Ltd. include Biop Digital Colposcope.