FDA.reportPublic FDA data

Mediworks

Primary DI
06945087500002
Brand
Mediworks
Company
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
Model
DEA520
Device description
Corneal topography system
Published
2022-11-02
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
06945087500002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945087500002069450875000026945087500002

GMDN Terms#

Term, Definition table
TermDefinition
Corneal topography systemAn assembly of ophthalmic devices used to measure the curvature and concentricity of the anterior corneal surface. It typically consists of a line-powered videokeratoscope using Placido imaging (involves disk with concentric white and black rings), and application software for installation in an included computer workstation, or external computer, for image processing and analysis. This device will be used to evaluate the need for refractive eye surgery, e.g., laser assisted in situ keratomileusis (LASIK) treatment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527884077
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945087505175MediworksScansys TA5172020-03-12
06945087516225MediworksFC1622021-05-18
06945087500026MediworksSM6212022-11-02
06945087500040MediWorksS2902022-11-02
06945087500057MediWorksSL650+2022-11-02
06945087500217MediWorksSL6502022-11-02
06945087515013MediworksS1502022-11-02
06945087520000MediworksRSL 21002021-05-17
06945087525005MediworksRSL 26002021-05-17
06945087525012MediworksRSL 2600digital2021-05-17
06945087590003MediworksTSL-900Z2021-05-17
06945087590010MediworksTSL-900H2021-05-17
06945087590027MediworksTSL-900Hdigital2021-05-17
06945087530023MediworksSL300L2021-05-10
06945087535066MediworksSL350H2021-05-10
06945087535073MediworksSL350L2021-05-10
06945087540015MediworksSL400H2021-05-10
06945087540022MediworksSL400L2021-05-10
06945087545010MediworksSL450H2021-05-10
06945087545027MediworksSL450L2021-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06972039971054MOPTIMShenzhen CERTAINN Technology Co., Ltd.MMQ2025-08-15
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
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