Moptim
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. •…
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.).
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| Shenzhen Certainn Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
Record
| Listed by | Shenzhen Certainn Technology Co., Ltd., China |
|---|---|
| FDA product code | HLR |
| Device type | Keratoscope, Battery-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1350 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 55 °C; Storage environment humidity 0 to 93 % RH; Storage environment atmospheric pressure 86 to 106 KiloPascal; Handling environment temperature 5 to 40 °C; Handling environment humidity 0 to 80 % RH; Handling environment atmospheric pressure 86 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DEA | In distribution |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.