FDA.reportPublic FDA data

Multifunction Unit

Primary DI
04582273613621
Brand
Multifunction Unit
Company
TOMEY CORPORATION.
Model
MR-6000
Published
2026-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
04582273613621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582273613621045822736136214582273613621

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.

Regulatory Flags#

DUNS number
696280002
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582273600263NON-CONTACT TONOMETERFT-10002022-04-01
04582273603691SPECULAR MICROSCOPEEM-40002022-04-01
04582273611740NON-CONTACT TONOMETERFT-10002016-10-18
04582273612150NON-CONTACT TONOMETERFT-10002016-09-21
04582273612167NON-CONTACT TONOMETERFT-10002016-10-18
04582273612822Specular MicroscopeEM-40002018-03-06
04582273604704Cornea/Anterior Segment OCTCASIA22023-06-07
04582273600218AUTO REFKERATOMETERRC-50002022-04-01
04582273600256AUTO REF-TOPOGRAPHERRT-70002022-04-01
04582273603714Topographic Modeling SystemTMS-4N2022-04-01
04582273604162Auto LensmeterTL-70002022-04-01
04582273611788AUTO REFKERATOMETERRC-8002022-04-01
04582273612679Auto LensmeterTL-60002022-04-01
04582273612242AUTO REFKERATOMETERRC-50002020-10-30
04582273612273AUTO REFKERATOMETERRC-8002020-10-30
04582273612297AUTO REF-TOPOGRAPHERRT-70002020-10-30
04582273612099TOPOGRAPHIC MODELING SYSTEMTMS-4N2020-10-30
04582273612129TOPOGRAPHIC MODELING SYSTEMTMS-4N2020-10-30
04582273612402AUTO LENSMETERTL-1002020-10-30
04582273612655AUTO LENSMETERTL-70002020-10-30

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
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