FDA.reportPublic FDA data

MOPTIM

Primary DI
06972039971054
Brand
MOPTIM
Company
Shenzhen CERTAINN Technology Co., Ltd.
Model
C1
Device description
C1 is a non-contact diagnostic method that measures the shape of the corneal surface, providing key parameters such as corneal curvature and refractive power. Utilizing an advanced Placido disk, it accurately captures topographical changes around the cornea and enables analysis of higher-order aberrations. This device is essential for routine ophthalmic examinations of the cornea.
Published
2025-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MMQTopographer, Corneal, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMQTopographer, Corneal, Ac-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972039971054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972039971054069720399710546972039971054

GMDN Terms#

Term, Definition table
TermDefinition
Corneal topography system analyserA mains electricity (AC-powered) ophthalmic device used to measure the curvature and concentricity of the anterior corneal surface. It is typically a dedicated videokeratoscope that uses Placido imaging (involves a disk with concentric white and black rings) to provide keratometric and topographic measurements and images. It will typically output to a dedicated computer workstation or external computer with installed dedicated application software.

Sterilization Methods#

Method table
Method

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
06972039971092MOPTIMARK-A12026-06-03
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
06972039971641MOPTIMDEA2022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04582273613621Multifunction UnitTOMEY CORPORATION.MMQ2026-10-08
08800019600992Auto Ref-Topographer HRKT-1Huvitz Co., Ltd.MMQ2026-01-30
06973211071623Corneal TopographerCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDMMQ2025-08-18
06973211071630Corneal TopographerCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDMMQ2025-08-18
08034028770609TERA Dry Eye ImagerVISIA IMAGING SRLMMQ2025-08-06
09349221000132Medmont Meridia Advanced Topographer VantageMEDMONT INTERNATIONAL PTY LTDMMQ2025-07-03
08800019600770Corneal Topographer HTG-1Huvitz Co., Ltd.MMQ2023-06-12
03662824001846TearCheck TE-SWINMMQ2023-03-06
03662824003048TearCheck TE-SWINMMQ2023-03-06
06945087500002MediworksSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.MMQ2022-11-02
09349221000101Medmont Meridia Advanced Topographer ProfessionalMEDMONT INTERNATIONAL PTY LTDMMQ2022-09-14
09349221000118Medmont Meridia Advanced Topographer ClassicMEDMONT INTERNATIONAL PTY LTDMMQ2022-09-14
04582273603714Topographic Modeling SystemTOMEY CORPORATION.MMQ2022-04-01
08719326059600CASSINICassini Technologies B.V.MMQ2021-03-03
04582273612099TOPOGRAPHIC MODELING SYSTEMTOMEY CORPORATION.MMQ2020-10-30
04582273612129TOPOGRAPHIC MODELING SYSTEMTOMEY CORPORATION.MMQ2020-10-30
06945087505175MediworksSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.MMQ2020-03-12
04049584000477Keratograph 5MOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMMQ2016-09-01