FDA.reportPublic FDA data

ME-CHECK 4

Primary DI
08056389701405
Brand
ME-CHECK 4
Company
ESPANSIONE MARKETING SPA
Model
ME-CHECK 4
Catalog number
ME-CHECK 4
Published
2023-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PJZCamera, Ophthalmic, General-Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJZCamera, Ophthalmic, General-UseOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056389701405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056389701405080563897014058056389701405

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose digital medical camera lens, extraocularA non-sterile optical device intended for attachment to a multi-purpose digital medical camera to provide high-resolution focusing of digital imaging data from the surface of the eye and adjacent areas. It may use white and/or blue light for the capture of specialized images (e.g., dry eye). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
339474539
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
08056389701115YOUNG AGAINYOUNG AGAIN2026-04-30
08056389701122EPI-C PLUSEPI-C PLUSEPI-C PLUS2026-04-30
08056389700194E-LIGHT LINEMASK LM YELLOW/CEMASK LM YELLOW/CE2018-06-06
08056389700019E-LIGHT LINEE-LIGHT DEVICEE-LIGHT DEVICE2019-11-21
08056389700095E-LIGHT LINELED MASKH-20LED MASK H-202019-09-03
08056389700118E-LIGHT LINELED MASKLED MASK2018-06-06
08056389700132E-LIGHT LINELED MASK/RED-05LED MASK/RED-052018-06-06
08056389700156E-LIGHT LINELED MASK/RED-20LED MASK/RED-202018-06-06
08056389700170E-LIGHT LINEMASK LM RED/CEMASK LM RED/CE2018-06-06
08056389700187E-LIGHT LINEMASK LM BLUE/CEMASK LM BLUE/CE2018-06-06
08056389700378MY MASK-EMY MASK-E/PSMY MASK-E/PS2020-05-25
08056389700385MY MASK-EMY MASK-E/M250MY MASK-E/M2502020-05-25
08056389700392MY MASK-EMY MASK-E/M500MY MASK-E/M5002020-05-25
08056389700408MY MASK-EMY MASK-E/M2000MY MASK-E/M20002020-05-25
08056389700217E-LIGHT LINELED MASK/BLUE-05LED MASK/BLUE-052019-05-24
08056389701009E-LIGHT LINEIPL LAMP-390 IPL LAMP-3902024-05-14
08056389701016E-LIGHT LINEIPL LAMP-550 IPL LAMP-5502024-05-14
08056389701023E-LIGHT LINEIPL LAMP-LSIPL LAMP-LS2024-05-14
08056389701030E-LIGHT LINEIPL LAMP-DSIPL LAMP-DS2024-05-14
08056389701047E-LIGHT LINEEPI-C PLUSEPI-C PLUS2024-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010859193OptaseScope Health Inc.PJZ2026-05-01
00860014277559MarcoLombart Brothers, Inc.PJZ2026-03-02
06430046260993Optomed Lumo Camera setOptomed OyPJZ2025-11-13
00860012447121EyeCasterInnovations Lightx IncPJZ2025-11-12
00860012447138EyeCasterInnovations Lightx IncPJZ2025-11-12
00860012447145EyeCasterInnovations Lightx IncPJZ2025-11-12
06973211070619Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPJZ2025-08-18
06973211071500Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPJZ2025-08-18
06973211071517Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPJZ2025-08-18
00850067214229identifeye Camera System, tabletIdentifeye Health Inc.PJZ2025-07-07
00850067214236identifeye Camera System, power supplyIdentifeye Health Inc.PJZ2025-07-07
00850067214274identifeye Camera SystemIdentifeye Health Inc.PJZ2025-07-07
00850067214281identifeye Camera System, reconditionedIdentifeye Health Inc.PJZ2025-07-07
06976107790301AirdocChangsha Airdoc Health Technology Co., Ltd.PJZ2024-09-27
07908616100097Eyer 2 BasicPHELCOM TECHNOLOGIES SAPJZ2024-09-23
00860011978305EntireEye PortableRETIVUE, LLCPJZ2024-07-18
00811608014708Volk VivaVOLK OPTICAL INC.PJZ2024-04-05
00811608014739Volk VivaVOLK OPTICAL INC.PJZ2024-04-05
00860010826812Oivi Opthalmic Fundus CameraOivi ASPJZ2024-01-15
00853501008002Spect Ophthalmic CameraSpect Inc.PJZ2023-08-10
10860000249543Verily Retinal CameraVERILY LIFE SCIENCES LLCPJZ2023-05-24
07908616100042EyerPHELCOM TECHNOLOGIES SAPJZ2023-04-27
00811608013770Volk VistaViewVOLK OPTICAL INC.PJZ2022-11-16
00850038195229Eli EzerU.S. OPHTHALMIC, L.L.C.PJZ2022-11-03
06945087500088MediworksSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.PJZ2022-11-02
00628678036017WRI-1Cellview Imaging Inc.PJZ2022-09-08
00628678036055WRI-1Cellview Imaging Inc.PJZ2022-09-08
06973211070008Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPJZ2022-06-08
08906096520052RemidioREMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITEDPJZ2022-01-31
18437014903024HD AnalyzerVISIOMETRICS SLPJZ2022-01-21