MOPTIM

Primary DI
06972039971641
Brand
MOPTIM
Company
Shenzhen CERTAINN Technology Co., Ltd.
Model
DEA
Device description
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.).
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HLRKeratoscope, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLRKeratoscope, Battery-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972039971641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972039971641069720399716416972039971641

GMDN Terms#

Term, Definition table
TermDefinition
Meibomian gland camera/ophthalmic interferometerA mains electricity (AC-powered) multi-purpose optical device intended for: 1) infrared (IR) image capture of the meibomian glands for evaluation of structural abnormalities of the meibomian glands; 2) measurement of the tear film lipid layer using white light image/video capture interferometry; and 3) image capture of the external ocular anatomy. It includes patient head/chin supports, an IR source(s), appropriate cameras, controls and software intended to allow analysis of the images/video and interferometry; it may include an eyelid everter to assist imaging of the meibomian glands.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Regulatory Flags#

DUNS number
526992561
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972039971054MOPTIMC12025-08-15
06972039971085MOPTIMeasyCam2025-06-30
06972039971016MOPTIMR2X2025-06-23
06972039971023MOPTIMR3X2025-06-23
06972039971061MOPTIMOPM500D2025-06-23
06972039971078MOPTIMOPM500C2025-06-23
06972039971221MOPTIMOPM5002025-06-23
06972039971214MOPTIMeasyRef Pro2025-06-19
06972039971573MOPTIMeasyRef2023-02-03
06972039971405MOPTIMSL-M62022-12-08
06972039971542MOPTIMiRef2022-12-08