illumigyn.comGynescope System
Illumigyn Ltd.
ILLUMIGYN LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016250458 | 3016250458 | ILLUMIGYN LTD. | 1 | N | 2026-01-01 | Communication Center Neve Ilan Neve Ilan Central IL 9085000 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 17290018240011 | GYNESCOPE , SYSTEM (CONSOLE, IMAGE ACQUISTION SYSTEM-1 pcs - 01 | +97225476319 | support@illumigyn.com |
| 27290018240018 | Gynescope single use vaginal speculume size small 60 units - Indications for UseGynescope single Use Vaginal Speculum The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The vaginal single use speculum can be used ONLY with the Gynescope™ system. | +97225476319 | support@illumigyn.com |
| 37290018240015 | Gynescope single use vaginal speculum size medium 60 units - Indications for UseGynescope Single Use Vaginal Speculum The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The vaginal single use speculum can be used ONLY with the Gynescope™ system | +97225476319 | support@illumigyn.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 236484 | 1080857343 | K190187 | Gynescope System | HEX | 2019-05-08 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HEX | 2 | 2019-05-08 |
PMN#
GUDID#
Gynescope, console system - Gynescope™ systemconsole for image capturing and digital image archiving
2020-11-26
Gynescope Image acquistion system - The Gynescope™ is an imaging colposcope. The Gynescope™ provides high resolution imaging optics comprised of multi-spectral (White and Green)illumination and multi-angle illumination dark field (side illumination) and bright field (centered illumination) techniques, reinforced with dual imaging sensordesign (a color imaging sensor and a high sensitivity monochrome sensor). The monochrome sensor and the color sensor have the same optical path. The opticaldesign uses a beam splitter adjacent to both of the sensors (at the end of the optical path).The Gynescope™ is a compact colposcope platform for physicians to performexaminations of the cervix, combined with a working space for interventionalprocedures. The Gynescope™ includes an Image Acquisition System
2020-11-26
Gynescope system, cart - 01
2020-11-26
GYNESCOPE , SYSTEM (CONSOLE, IMAGE ACQUISTION SYSTEM-1 pcs - 01
2020-11-20
Gynescope single use vaginal speculume size small 60 units - Indications for UseGynescope single Use Vaginal Speculum The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The vaginal single use speculum can be used ONLY with the Gynescope™ system.
2020-09-25
Gynescope single use vaginal speculum size medium 60 units - Indications for UseGynescope Single Use Vaginal Speculum The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The vaginal single use speculum can be used ONLY with the Gynescope™ system
2020-09-25
Gynescope single use vaginal speculum size large 60 units - Indications for UseGynescope Single Use Vaginal Speculum The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The vaginal single use speculum can be used ONLY with the Gynescope™ system.
2020-09-25
Gynescope single use vaginal speculum size Sm + Md + Lrg 20 pcs each - 20 units with small size20 units with medium size20 units with lager size.Indications for UseGynescope Single Use Vaginal Speculum The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The vaginal single use speculum can be used ONLY with the Gynescope system.
2020-09-25