Singapore - engelsk - HSA (Health Sciences Authority)

ophthalmic instruments (pte. ltd.) - ophthalmology - it is intended to be used as a wide field and retinal fluorescence and autofluorescence imaging ophthalmoscope to aide in the diagnosis and monitoring of diseases or disorders that manifest in the retina.

Singapore - engelsk - HSA (Health Sciences Authority)

ophthalmic instruments (pte. ltd.) - ophthalmology - the p200txe is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo digital imaging of posterior ocular structures, including the vitro-retinal interface, retina, retinal layers, optic disc, choroid and choroido-scleral interface. it is indicated for producing high-resolution, widefield, en-face reflectance images, auto fluorescence images, fluorescein angiography images, indocyanine green angiography images, and axial cross-sectional images of the posterior ocular structures. the system enables practitioners to capture multi-modal images in support of detection, investigation and monitoring of retinal conditions.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

yes medical - 12815 - ophthalmoscope, - intended to illuminate and facilitate examining the interior structures of the eye such as the retina.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

medeleq australia pty ltd - 45084 - ophthalmologic/otologic diagnostic set - eent and physical examination instruments for examination of the inner ear, eye and skin.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

lead business group medical pty ltd - 45084 - ophthalmologic/otologic diagnostic set - eent and physical examination instruments for examination of the inner ear, eye and skin.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

optos australia pty ltd - 64004 - scanning-laser ophthalmoscope/retinal optical coherence tomography system - the p200te is a non-contact scanning laser ophthalmoscope and optical coherence tomographer. it is intended for in-vivo viewing, digital imaging, and analysis of posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell complex (gcc) and optic disc, under mydriatic and non-mydriatic conditions. it is indicated for producing high resolution, ultra-widefield, en face reflectance images, autofluorescence images, axial cross-sectional images, three-dimensional images, retinal layer boundary analysis, optic nerve head analysis and thickness maps. the p200te system includes a reference database, allowing results of oct analysis to be compared to reference data. the p200te is indicated for use as a device to aid in the detection, diagnosis, documentation and management of retinal health and diseases that manifest in the retina.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

optos australia pty ltd - 64004 - scanning-laser ophthalmoscope/retinal optical coherence tomography system - the p200txe is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo digital imaging of posterior ocular structures, including the vitro-retinal interface, retina, retinal layers, optic disc, choroid and choroido-scleral interface. it is indicated for producing high-resolution, wide field, en-face reflectance images, auto fluorescence images, fluorescein angiography images, indocyanine green angiography images, and axial cross-sectional images of the posterior ocular structures. the system enables practitioners to capture multi-modal images in support of detection, investigation and monitoring of retinal conditions.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

welch allyn australia pty limited - 65470 - direct ophthalmoscope eye cup - the device is intended to be attached to the distal (patient-contact) end of a direct ophthalmoscope head to facilitate appropriate positioning around the patient?s eye socket during an examination.

Singapore - engelsk - HSA (Health Sciences Authority)

molnlycke health care asia-pacific pte ltd - ophthalmology - ophthalmology tray is intended for single-use to enable a suitable trained health care professional to perform an ophthalmic procedure.

Tanzania - engelsk - Tanzania Medicinces & Medical Devices Authority

eto (t) ltd, tanzania - wireless indirect ophthalmoscope -