Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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RetCam™ Envision 130 Degree Lens
XLTEK
60-000090
In Commercial Distribution

  • 00382830058674 ()


  • Ophthalmic fundus camera
RetCam Envision with FA
XLTEK
61-000300
In Commercial Distribution

  • 00382830056335 ()


  • Ophthalmic fundus camera
NIDEK DS-20 is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus (including retina, macula and optic disc) of the human eye and surrounding area. DS-20 consists of control unit and optical lens DS-20F (Digital Eye Fundus Camera).
NIDEK CO.,LTD.
DS-20 Control Unit
In Commercial Distribution

  • 04987669101087 ()


  • Ophthalmic fundus camera
NIDEK DS-20 is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus (including retina, macula and optic disc) of the human eye and surrounding area.
NIDEK CO.,LTD.
DS-20F
In Commercial Distribution

  • 04987669101001 ()


  • Ophthalmic fundus camera
NIDEK DS-10F is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus (including retina, macula and optic disc) of the human eye and surrounding area.
NIDEK CO.,LTD.
DS-10F
In Commercial Distribution

  • 04987669100998 ()


  • Ophthalmic fundus camera
The device WRI-1 is an ophthalmic imaging device and intended to be used by health care professionals to capture, display, and store color and monochrome images of the retina without contact to the patient eye.
Cellview Imaging Inc.
01
In Commercial Distribution

  • 00628678036017 ()


  • Ophthalmic fundus camera
KOWA nonmyd AF is intended for use with retinal image capturing without requiring the patients to take any mydriatic.
KOWA COMPANY,LTD.
K9L64K
In Commercial Distribution

  • 04987646809128 ()


  • Ophthalmic fundus camera
The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.
KOWA COMPANY,LTD.
DE2K
Not in Commercial Distribution

  • 04987646807728 ()


  • Ophthalmic fundus camera
The KOWA nonmyd 8s is intended for use with retinal image capturing without mydriatic.
KOWA COMPANY,LTD.
K9L63K
In Commercial Distribution

  • 04987646807612 ()

  • Height: 548 Millimeter
  • Depth: 504 Millimeter
  • Width: 310 Millimeter
  • Weight: 21 Kilogram


  • Ophthalmic fundus camera
The KOWA nonmyd 8 is intended for use with retinal image capturing without mydriatic.
KOWA COMPANY,LTD.
K9L61K
In Commercial Distribution

  • 04987646807575 ()

  • Width: 310 Millimeter
  • Depth: 504 Millimeter
  • Height: 548 Millimeter
  • Weight: 21 Kilogram


  • Ophthalmic fundus camera
KOWA nonmyd 7 is intended for use with retina image capturing without mydriatic. The retina image can be stored to an image filing equipment through serial interface.
KOWA COMPANY,LTD.
K9L39F9K
In Commercial Distribution

  • 04987646807360 ()

  • Depth: 504 Millimeter
  • Height: 548 Millimeter
  • Width: 310 Millimeter
  • Weight: 21 Kilogram


  • Ophthalmic fundus camera
KOWA nonmyd WX is intended for use with plane and stereo retinal image capturing without mydriatic. The retina image can be stored to an image filing derive through serial interface.
KOWA COMPANY,LTD.
K9L57FK
In Commercial Distribution

  • 04987646806592 ()

  • Height: 548 Millimeter
  • Depth: 504 Millimeter
  • Width: 310 Millimeter
  • Weight: 21 Kilogram


  • Ophthalmic fundus camera
KOWA VX-10a is intended for taking pictures of fundus images with mydriatic or without mydriatic.
KOWA COMPANY,LTD.
K9L48BK
In Commercial Distribution

  • 04987646804147 ()

  • Height: 620 Millimeter
  • Depth: 520 Millimeter
  • Width: 400 Millimeter
  • Weight: 35.5 Kilogram


  • Ophthalmic fundus camera
The Kowa hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.
KOWA COMPANY,LTD.
K9L51K
In Commercial Distribution

  • 04987646803973 ()

  • Power supply unit Weight: 1930Grams, Width: 180mm, Depth: 300mm, Height: 230mm
  • Camera unit Weight: 1070 Grams, Width: 74.5mm, Depth: 197mm, Height: 278.5mm


  • Ophthalmic fundus camera
KOWA VX-10 is intended for taking pictures of fundus images with mydriatic or without mydriatic.
KOWA COMPANY,LTD.
K9L48K
In Commercial Distribution

  • 04987646802006 ()

  • Height: 620 Millimeter
  • Depth: 520 Millimeter
  • Width: 400 Millimeter
  • Weight: 39 Kilogram


  • Ophthalmic fundus camera
KOWA nonmyd a-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic. The retinal image can be stored to an image filing drive through serial interface.
KOWA COMPANY,LTD.
K9L58K
In Commercial Distribution

  • 04987646800606 ()

  • Height: 462 Millimeter
  • Depth: 505 Millimeter
  • Width: 310 Millimeter
  • Weight: 22 Kilogram


  • Ophthalmic fundus camera
KOWA GENESIS-Df is a device intended to capture and save fundus images with mydriatic.
KOWA COMPANY,LTD.
K9L51BK
In Commercial Distribution

  • 04987646800583 ()

  • Power supply unit Weight: 1930Grams, Width: 180mm, Depth: 300mm, Height: 230mm
  • Camera unit Weight: 1070Grams, Width: 74.5mm, Depth: 197mm, Height: 278.5mm


  • Ophthalmic fundus camera
Mydriatic Hyperspectral Retinal Camera (MHRC-C1)
Optina Diagnostiques, Inc
MHRC-C1
In Commercial Distribution

  • 00627987702125 ()


  • Ophthalmic fundus camera
Automated Portable Retinal Camera
CRYSTALVUE MEDICAL CORPORATION
VitaziView
In Commercial Distribution

  • 04719876420398 ()
700-C2701-431

  • Ophthalmic fundus camera
Automated Portable Retinal Camera
CRYSTALVUE MEDICAL CORPORATION
Halo
In Commercial Distribution

  • 04719876420275 ()
700-C2701-131

  • Ophthalmic fundus camera
Automated Portable Retinal Camera
CRYSTALVUE MEDICAL CORPORATION
NFC-600
In Commercial Distribution

  • 04719876420268 ()
700-C2701-031

  • Ophthalmic fundus camera
Non-Mydriatic Auto Fundus Camera
CRYSTALVUE MEDICAL CORPORATION
Polaris
In Commercial Distribution

  • 04719876420176 ()
700-C1101-431

  • Ophthalmic fundus camera
Non-Mydriatic Auto Fundus Camera
CRYSTALVUE MEDICAL CORPORATION
RetinaStation
In Commercial Distribution

  • 04719876420060 ()
700-C1101-231

  • Ophthalmic fundus camera
Non-Mydriatic Auto Fundus Camera
CRYSTALVUE MEDICAL CORPORATION
NFC-700
In Commercial Distribution

  • 04719876420053 ()
700-C1101-031

  • Ophthalmic fundus camera
Eye Fundus Camera: RetinaVue 700 Imager (RV700-B)
MEDIMAGING INTEGRATED SOLUTION INC.
1008
In Commercial Distribution

  • 04719872711162 ()


  • Ophthalmic fundus camera
Eye Fundus Camera: RetinaVue 700 Imager (RV700TUD-B)
MEDIMAGING INTEGRATED SOLUTION INC.
1008
In Commercial Distribution

  • 04719872711155 ()


  • Ophthalmic fundus camera
Eye Fundus Camera: RetinaVue 700 Imager (RV700TU-B)
MEDIMAGING INTEGRATED SOLUTION INC.
1008
In Commercial Distribution

  • 04719872711148 ()


  • Ophthalmic fundus camera
Eye Fundus Camera: RetinaVue 700 Imager (RV700B)
MEDIMAGING INTEGRATED SOLUTION INC.
1008
In Commercial Distribution

  • 04719872711131 ()


  • Ophthalmic fundus camera
Eye Fundus Camera: RetinaVue 100 Imager (RV100PRO-C)
MEDIMAGING INTEGRATED SOLUTION INC.
1007
In Commercial Distribution

  • 04719872711124 ()


  • Ophthalmic fundus camera
Eye Fundus Camera: RetinaVue 100 Imager (RV100PROC)
MEDIMAGING INTEGRATED SOLUTION INC.
1007
In Commercial Distribution

  • 04719872711117 ()


  • Ophthalmic fundus camera
Mydriatic Hyperspectral Retinal Camera (MHRC-C1N)
Optina Diagnostiques, Inc
MHRC-C1N
In Commercial Distribution

  • 00627987702132 ()


  • Ophthalmic fundus camera
3nethra classic 6.4 is a non-mydriatic device for imaging the posterior and anterior surfaces of human eye. It assists clinicians in the evaluation and documentation of visual health.
FORUS HEALTH PRIVATE LIMITED
classic 6.4
In Commercial Distribution

  • 08908007754143 ()


  • Ophthalmic fundus camera
3nethra classic is a compact, portable and easy-to-use ophthalmic camera that supports non-mydriatic imaging mode. It is designed to acquire, display and store images of the posterior and anterior surfaces of the human eye
FORUS HEALTH PRIVATE LIMITED
classic stand
In Commercial Distribution

  • 08908007754129 ()


  • Ophthalmic fundus camera
3nethra classic is a compact, portable and easy-to-use ophthalmic camera that supports non-mydriatic imaging mode. It is designed to acquire, display and store images of the posterior and anterior surfaces of the human eye
FORUS HEALTH PRIVATE LIMITED
classic camera
In Commercial Distribution

  • 08908007754112 ()


  • Ophthalmic fundus camera
3nethra classic HD is an ophthalmic camera intended to capture and document digital images of the human eye.
FORUS HEALTH PRIVATE LIMITED
classic HD stand
In Commercial Distribution

  • 08908007754105 ()


  • Ophthalmic fundus camera
3nethra classic HD is an ophthalmic camera intended to capture and document digital images of the human eye.
FORUS HEALTH PRIVATE LIMITED
classic HD camera
In Commercial Distribution

  • 08908007754099 ()


  • Ophthalmic fundus camera
3nethra neo is a contact device to capture digital color images of the retina of infants having less than 55 weeks of Post Menstrual Age (PMA), while their eyes are dilated using mydriatic drops under clinical control.
FORUS HEALTH PRIVATE LIMITED
neo control box
In Commercial Distribution

  • 08908007754075 ()


  • Ophthalmic fundus camera
3nethra neo is a contact device to capture digital color images of the retina of infants having less than 55 weeks of Post Menstrual Age (PMA), while their eyes are dilated using mydriatic drops under clinical control.
FORUS HEALTH PRIVATE LIMITED
neo probe
In Commercial Distribution

  • 08908007754068 ()


  • Ophthalmic fundus camera
The 3nethra neo P1000 is a mydriatic digital imaging camera used for capturing and storing images of the human retina. The device acquires only digital photographs of the eye and does not provide any analysis or diagnosis. The 3nethra neo has a hand-held probe, a control unit, and a foot pedal. Components such as warm white LEDs, lenses, aperture, sensitive photodetector arrays (CMOS sensor array) are housed in the probe. The light emitted is within the safe limits of group 1 radiant exposure specifications for ultraviolet, visible, and infrared radiation under all light energy conditions, as defined in the 15004-2 (and ANSI Z80.36-2016) Light Hazard Protection standards for Ophthalmic Instruments. 3nethra neo includes an application software that facilitates the capture, storage, and retrieval of images. Illumination and focus are adjusted using a foot pedal.
FORUS HEALTH PRIVATE LIMITED
neo P1000 control box
In Commercial Distribution

  • 08908007754051 ()


  • Ophthalmic fundus camera
The 3nethra neo P1000 is a mydriatic digital imaging camera used for capturing and storing images of the human retina. The device acquires only digital photographs of the eye and does not provide any analysis or diagnosis. The 3nethra neo has a hand-held probe, a control unit, and a foot pedal. Components such as warm white LEDs, lenses, aperture, sensitive photodetector arrays (CMOS sensor array) are housed in the probe. The light emitted is within the safe limits of group 1 radiant exposure specifications for ultraviolet, visible, and infrared radiation under all light energy conditions, as defined in the 15004-2 (and ANSI Z80.36-2016) Light Hazard Protection standards for Ophthalmic Instruments. 3nethra neo includes an application software that facilitates the capture, storage, and retrieval of images. Illumination and focus are adjusted using a foot pedal.
FORUS HEALTH PRIVATE LIMITED
neo P1000 probe
In Commercial Distribution

  • 08908007754044 ()


  • Ophthalmic fundus camera
3nethra neo is a contact device to capture digital color images of the retina of infants having less than 55 weeks of Post Menstrual Age (PMA), while their eyes are dilated using mydriatic drops under clinical control.
FORUS HEALTH PRIVATE LIMITED
neo control box
In Commercial Distribution

  • 08908007754037 ()


  • Ophthalmic fundus camera
3nethra neo is a contact device to capture digital color images of the retina of infants having less than 55 weeks of Post Menstrual Age (PMA), while their eyes are dilated using mydriatic drops under clinical control.
FORUS HEALTH PRIVATE LIMITED
neo probe
In Commercial Distribution

  • 08908007754020 ()


  • Ophthalmic fundus camera
No Description
FORUS HEALTH PRIVATE LIMITED
Stand
In Commercial Distribution

  • 08908007754013 ()


  • Ophthalmic fundus camera
3nethra classic camera is a non-mydriatic digital imaging device. It is designed to acquire, display, store and transmit images of the posterior and anterior surfaces of the human eye.
FORUS HEALTH PRIVATE LIMITED
Classic camera
In Commercial Distribution

  • 08908007754006 ()


  • Ophthalmic fundus camera
No Description
TOPCON CORPORATION
NW500
In Commercial Distribution

  • 04571130283152 ()


  • Ophthalmic fundus camera
No Description
TOPCON CORPORATION
TRC-NW400
In Commercial Distribution

  • 04571130283022 ()


  • Ophthalmic fundus camera
No Description
TOPCON CORPORATION
TRC-50DX
In Commercial Distribution

  • 04571130282643 ()


  • Ophthalmic fundus camera
No Description
TOPCON CORPORATION
TRC-50DX
In Commercial Distribution

  • 04571130282636 ()


  • Ophthalmic fundus camera
No Description
TOPCON CORPORATION
EF-2
In Commercial Distribution

  • 04562123289923 ()


  • Ophthalmic fundus camera
No Description
TOPCON CORPORATION
IF-1
In Commercial Distribution

  • 04562123289893 ()


  • Ophthalmic fundus camera
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