Illumigyn, Ltd.
IsraelFDA 510(k) applicant, unverified FDA
- Devices
- 9
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Illumigyn, Ltd. makes
Illumigyn, Ltd. manufactures video colposcope systems, including single-use vaginal speculums in small, medium, and large sizes, as well as console-based image acquisition units. Their products are designed for gynecological examinations, combining speculum attachments with digital imaging capabilities for enhanced visualization.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI registries. Illumigyn, Ltd. is based in the United States.
Catalogue
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
Gynescope System Ref K190187
510(k) 510(k)
Company details
- DUNS number
- 600627621
- [email protected]
- Phone
- +97225476319
FDA establishments
- Illumigyn Ltd. Neve Ilan Central · IL FEI 3016250458
Frequently asked questions
How many devices does Illumigyn, Ltd. have in the registry?
The registry currently lists 9 devices for Illumigyn, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Illumigyn, Ltd.'s devices?
Among its 9 most recently registered devices, Illumigyn, Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (8 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Illumigyn, Ltd.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Illumigyn, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Illumigyn, Ltd. in the registry?
The most recently registered devices listed for Illumigyn, Ltd. include Gynescope single use vaginal speculume size small 60 units 01, Gynescope system, cart 01, Gynescope single use vaginal speculum size large 60 units 01 and GYNESCOPE, SYSTEM (CONSOLE, IMAGE ACQUISTION SYSTEM-1 pcs 01.
Which FDA establishments are linked to Illumigyn, Ltd.?
1 FDA establishment is linked to Illumigyn, Ltd. in the registry; they are listed on the company page.