FDA.reportPublic FDA data

Remidio

Primary DI
08906096520021
Brand
Remidio
Company
REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED
Model
AIM
Catalog number
3231680012
Device description
Anterior Imaging Module (AIM) is intended for screening, capture and storage of images of the Anterior part of eye and surrounding area, AIM camera is designed to be attached to any existing 3 step or 5 step slit lamps for true colour and monochrome imaging in visible spectrum of light. The camera of a smart phone is used to capture images of the eye. The device can be used at any time & over & over again by a trained user.
Published
2020-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08906096520021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08906096520021089060965200218906096520021

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic slit lamp, examinationA mains electricity (AC-powered), ophthalmic, binocular microscope designed to examine the interior anatomy of the eye (anterior and posterior surfaces) by viewing through the iris. It produces a narrow slit of powerful light which is projected into the eye, and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular surfaces. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 KiloPascal1060 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
650711448
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08906096520076RemidioINSTAREF R2010000100212023-07-06
08906096520083RemidioREM-90010100100052023-07-06
08906096520052RemidioRemidio FOP2022-01-31
08906096520069RemidioRemidio Connect2022-01-31
08906096520038RemidioMRD-106507114482021-11-26
08906096520045RemidioPSL - D2032316800182021-11-26
08906096520014Remidio 0012019-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860012447145EyeCasterInnovations Lightx IncPJZ2025-11-12
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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
08056389701405ME-CHECK 4ESPANSIONE MARKETING SPAPJZ2023-04-05
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