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The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source),
documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for
endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon,
colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioning
within the lumen and help control the endoscope’s view field and/or endoscope positioning.
SMART MEDICAL SYSTEMS LTD
G-EYE760Z-V/L
In Commercial Distribution
- 07290018671047 ()
40-596
- Flexible fibreoptic colonoscope
The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source),
documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for
endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon,
colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioning
within the lumen and help control the endoscope’s view field and/or endoscope positioning.
SMART MEDICAL SYSTEMS LTD
G-EYE760S-V/L
In Commercial Distribution
- 07290018671030 ()
40-596
- Flexible fibreoptic colonoscope
The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source),
documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for
endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon,
colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioning
within the lumen and help control the endoscope’s view field and/or endoscope positioning
SMART MEDICAL SYSTEMS LTD
G-EYE760P-V/L
In Commercial Distribution
- 07290018671023 ()
40-596
- Flexible fibreoptic colonoscope
The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source),
documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for
endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon,
colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioning
within the lumen and help control the endoscope’s view field and/or endoscope positioning.
SMART MEDICAL SYSTEMS LTD
G-EYE760ZP-V/L
In Commercial Distribution
- 07290018671016 ()
40-596
- Flexible fibreoptic colonoscope
The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source),
documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for
endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon,
colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioning
within the lumen and help control the endoscope’s view field and/or endoscope positioning.
SMART MEDICAL SYSTEMS LTD
G-EYE760R-V/L
In Commercial Distribution
- 07290018671009 ()
40-596
- Flexible fibreoptic colonoscope
The Slit Lamp comprises an illumination and a Binocular Microscope. The entire device can be moved in front of the eye using the instrument base. The illumination offers a range of setting possibilities for making the practically invisible areas of the eye visible. There is also a range of accessories available for the Slit Lamp to allow special diagnosis possibilities in addition to the general examinations. A camera may be attached to the slit lamp to take photographs of different parts of the eye.
Shenzhen CERTAINN Technology Co., Ltd.
SL-M6
In Commercial Distribution
- 06972039971405 ()
- Ophthalmic examination slit lamp
No Description
Wuxi Hisky Medical Technologies Co.,Ltd.
Mini800
In Commercial Distribution
- 06971679949072 ()
- Hepatic ultrasound elastography system
No Description
Wuxi Hisky Medical Technologies Co.,Ltd.
FT100
In Commercial Distribution
- 06971679949065 ()
- Hepatic ultrasound elastography system
No Description
Wuxi Hisky Medical Technologies Co.,Ltd.
FT-2.5D9
In Commercial Distribution
- 06971679947023 ()
- Hepatic ultrasound elastography system applicator
No Description
Wuxi Hisky Medical Technologies Co.,Ltd.
FT-3.5R65
In Commercial Distribution
- 06971679947016 ()
- Extracorporeal ultrasound imaging transducer, hand-held
No Description
Wuxi Hisky Medical Technologies Co.,Ltd.
FT9000
In Commercial Distribution
- 06971679945005 ()
- Hepatic ultrasound elastography system
The DEA is intended to do the exams related to the analysis and possible diagnosis of Dry Eye Disease(DED) through the connection of the device to you pc, and particularly.
• Interferometry: records a video to the patient’s eye to analyze quantitatively and qualitatively lipid layer of the tear film, to compare it with the related grading scale and save the value;
• Tear Meniscus Hight: The tear secretion of the lacrimal layer was assessed by measuring the height of the tear meniscus;
• NIBUT: recording a video, it allows to evaluate the stability of the tear film between the break up time in a non-invasive way and to save the value;
• Fluorescein BUT: records a video for the evaluation of the tear film’s stability, but it is done with instillation of the fluorescein in the patient’s eye
(invasive) and without cone;
• Meibography: takes a picture of meibomian glands using infrared light. The device can analyze automatically the loss area of the glands to compare it with the related grading scale;
• Additional exams: checks for Bulbar Redness, Blepharitis, Demodex, pupillometry.
All the exams that can be performed with the DEA are of fundamental importance for the ophthalmologist and the optometrist (within their respective professional skins) to study the tear film and for coaching the exams done with the classic instruments (Slit Lamp, Topography, Tonometry, etc.).
Shenzhen CERTAINN Technology Co., Ltd.
DEA
In Commercial Distribution
- 06972039971641 ()
- Meibomian gland camera/ophthalmic interferometer
The key technique used in the easyRef Handheld Auto Refractometer is based on principle of Hartmann wave-front sensing.
Light is emitted from the light source system inside the device, and then focuses on the bottom of the eye through the spectroscope and exit port, then the light is reflected back to the device,
and beam through lens system and received by CCD camera. It is possible to calculate the diopter of the human eye by detecting the offset between the relative calibration light and the spot array formed by the light spot of each sub-aperture.
Shenzhen CERTAINN Technology Co., Ltd.
easyRef
In Commercial Distribution
- 06972039971573 ()
- Automated ophthalmic refractometer
The manual refractometer is composed of a lens and a removable eye chart. The testee is required to move the position of the eye chart after resetting to make the visual target become clearer from blur. Once the clearest position of the visual target is determined, the testee’s estimated refractive error can be read from the display screen of the instrument.
Shenzhen CERTAINN Technology Co., Ltd.
iRef
In Commercial Distribution
- 06972039971542 ()
- Hand-held subjective ophthalmic refractometer
This product is composed of the Full HD Endoscopic Image Processor, the foot switch, the power cable and video cable. Video cable includes SDI video cable and DVI video cable. The foot switch is optional.
This product is used in combination with Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P) to process the image collected by the electronic endoscope and transfer them to the monitor for imaging.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
HDVS-S200C
In Commercial Distribution
- 06971381252552 ()
- Endoscopic video image processing unit
This product is composed of the Full HD Endoscopic Image Processor, the foot switch, the power cable and video cable. Video cable includes SDI video cable and DVI video cable. The foot switch is optional.
This product is used in combination with Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P) to process the image collected by the electronic endoscope and transfer them to the monitor for imaging.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
HDVS-S200A
In Commercial Distribution
- 06971381252538 ()
- Endoscopic video image processing unit
The product is composed of full HD visualization endoscopic image processor, power supply adapter and power cables. This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
HDVS-S300D
In Commercial Distribution
- 06971381252422 ()
- Endoscopic video image processing unit
The product is composed of full HD visualization endoscopic image processor, power supply adapter and power cables. This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
HDVS-S300C
In Commercial Distribution
- 06971381252415 ()
- Endoscopic video image processing unit
The product is composed of full HD visualization endoscopic image processor, power supply adapter and power cables. This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
HDVS-S300B
In Commercial Distribution
- 06971381252408 ()
- Endoscopic video image processing unit
The product is composed of full HD visualization endoscopic image processor, power supply adapter and power cables. This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
HDVS-S300A
In Commercial Distribution
- 06971381252392 ()
- Endoscopic video image processing unit
The product is composed of a distal end, a bending section, an insertion section, an operation section, and a plug section.This Single-use Broncho Videoscope is intended to use in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of respiratory system such as trachea, bronchi, and lungs.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
SBV-1C-P
Not in Commercial Distribution
- 16971381252382 ()
- 06971381252385 ()
- Flexible video bronchoscope, single-use
The product is composed of a distal end, a bending section, an insertion section, an operation section, and a plug section. This Single-use Broncho Videoscope is intended to use in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of respiratory system such as trachea, bronchi, and lungs.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
SBV-1A-B
In Commercial Distribution
- 16971381252337 ()
- 06971381252330 ()
- Flexible video bronchoscope, single-use
Scivita 4KINSIGHT ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.
The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, including but not limited the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), colon, liver and uterus, using near infrared imaging. Fluorescence imaging of biliary ducts, colon, liver and uterus, with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for visualization of biliary duct, colon, liver and uterus.
4K UHD Laparoscope is intended to be used for imaging and observation during endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.The product is composed of eyepiece, lens body, optic fiber interface and adapter.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
4K5545LR
In Commercial Distribution
- 16971381252153 ()
- 06971381252156 ()
- Rigid optical laparoscope
The Scivita 4KINSIGHT ICG Imaging System consists of a 4KINSIGHT UHD Fluorescence Imaging System, a Near-Infrared LED Light Source, and a 4K UHD LAPAROSCOPE.
Upon intravenous administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used with TRADENAME to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography.
The Scivita 4KINSIGHT ICG Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Upon interstitial administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
4KIR07
In Commercial Distribution
- 06971381251517 ()
- Endoscopic video image processing unit
The Scivita 4KINSIGHT ICG Imaging System consists of a 4KINSIGHT UHD Fluorescence Imaging System, a Near-Infrared LED Light Source, and a 4K UHD LAPAROSCOPE.
Upon intravenous administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used with TRADENAME to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography.
The Scivita 4KINSIGHT ICG Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Upon interstitial administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
4KIR01
In Commercial Distribution
- 06971381251456 ()
- Endoscopic video image processing unit
Scivita 4KINSIGHT ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.
The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, including but not limited the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), colon, liver and uterus, using near infrared imaging. Fluorescence imaging of biliary ducts, colon, liver and uterus, with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for visualization of biliary duct, colon, liver and uterus.
4K UHD Laparoscope is intended to be used for imaging and observation during endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.The product is composed of eyepiece, lens body, optic fiber interface and adapter.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
4K1045LR
In Commercial Distribution
- 16971381251422 ()
- 06971381251425 ()
- Rigid optical laparoscope
Scivita 4KINSIGHT ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.
The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, including but not limited the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), colon, liver and uterus, using near infrared imaging. Fluorescence imaging of biliary ducts, colon, liver and uterus, with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for visualization of biliary duct, colon, liver and uterus.
4K UHD Laparoscope is intended to be used for imaging and observation during endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.The product is composed of eyepiece, lens body, optic fiber interface and adapter.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
4K1045L
In Commercial Distribution
- 16971381251415 ()
- 06971381251418 ()
- Rigid optical laparoscope
Scivita 4KINSIGHT ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.
The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, including but not limited the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), colon, liver and uterus, using near infrared imaging. Fluorescence imaging of biliary ducts, colon, liver and uterus, with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for visualization of biliary duct, colon, liver and uterus.
4K UHD Laparoscope is intended to be used for imaging and observation during endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.The product is composed of eyepiece, lens body, optic fiber interface and adapter.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
4K1030LR
In Commercial Distribution
- 16971381251408 ()
- 06971381251401 ()
- Rigid optical laparoscope
Scivita 4KINSIGHT ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.
The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, including but not limited the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), colon, liver and uterus, using near infrared imaging. Fluorescence imaging of biliary ducts, colon, liver and uterus, with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for visualization of biliary duct, colon, liver and uterus.
4K UHD Laparoscope is intended to be used for imaging and observation during endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.The product is composed of eyepiece, lens body, optic fiber interface and adapter.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
4K1030L
In Commercial Distribution
- 16971381251392 ()
- 06971381251395 ()
- Rigid optical laparoscope
Scivita 4KINSIGHT ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.
The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, including but not limited the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), colon, liver and uterus, using near infrared imaging. Fluorescence imaging of biliary ducts, colon, liver and uterus, with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for visualization of biliary duct, colon, liver and uterus.
4K UHD Laparoscope is intended to be used for imaging and observation during endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.The product is composed of eyepiece, lens body, optic fiber interface and adapter.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
4K1000LR
In Commercial Distribution
- 16971381251385 ()
- 06971381251388 ()
- Rigid optical laparoscope