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. •…

Registry build 21.09.26

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.).

3manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (2), Guangdong (1).

Chinese manufacturers registered for FDA product code HLR
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

Regulatory record for Moptim
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

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 numbers for Moptim
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer