Remidio

GUDID 08906096520052

Remidio FOP application along with FOP NM-10 hardware is intended for use in capturing & storing images of the retina and surrounding area of eye, with or without the use of Mydriatic agent and presenting the data to clinicians for evaluation or diagnosis. Light from the device is shown into the patient eye & the camera of a smartphone is used to capture images of the eye.

REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED

Ophthalmic image analysis software

• Primary Device ID: 08906096520052
• NIH Device Record Key: b48b402d-452a-4e41-8214-1abf31c63a07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Remidio
• Version Model Number: Remidio FOP
• Company DUNS: 650711448
• Company Name: REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08906096520052 [Primary]

FDA Product Code

• PJZ: Camera, Ophthalmic, General-Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-08
• Device Publish Date: 2022-01-31

On-Brand Devices [Remidio]

• 08906096520014: FOP NM-10 is indicated for screening, capture and storage of images of the eye and surrounding a
• 08906096520021: Anterior Imaging Module (AIM) is intended for screening, capture and storage of images of the An
• 08906096520045: Remidio Portable Slit Lamp (PSL-D20) is a handheld digital device for anterior segment screenin
• 08906096520038: Remidio Microscope Recording device MRD-10 is a device attached to a surgical microscope & is us
• 08906096520069: Remidio Connect is web-based application it is intended for displaying, storing images and data
• 08906096520052: Remidio FOP application along with FOP NM-10 hardware is intended for use in capturing & storing
• 08906096520083: The Auto ref/keratometer is used to measure the spherical, cylinder, axial, PD, corneal radius a
• 08906096520076: Remidio Instaref is an Ophthalmic auto refractometer intended to measure the refractive power of