SeeNA SEENA006100

GUDID 08034028770470

INTEGRATED DEVICE OCULAR BIOMETER AND CORNEAL ANALYZER

VISIA IMAGING SRL

Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser

• Primary Device ID: 08034028770470
• NIH Device Record Key: 64eae82e-3bb5-4bd3-b223-c9c087bb9ac8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SeeNA
• Version Model Number: SeeNA
• Catalog Number: SEENA006100
• Company DUNS: 447668039
• Company Name: VISIA IMAGING SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08034028770470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160327

FDA Product Code

• HJO: Biomicroscope, Slit-Lamp, Ac-Powered

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: 2023-06-05
• Device Publish Date: 2023-05-26

Devices Manufactured by VISIA IMAGING SRL

• 08034028770487 - MYAH: 2023-10-20
• 08034028770470 - SeeNA: 2023-06-05INTEGRATED DEVICE OCULAR BIOMETER AND CORNEAL ANALYZER
• 08034028770470 - SeeNA: 2023-06-05 INTEGRATED DEVICE OCULAR BIOMETER AND CORNEAL ANALYZER
• 08034028770463 - MYOPIA EXPERT 700: 2022-06-30 BIOMETER - TOPOGRAPHER
• 08034028770456 - MYAH: 2022-06-22
• 08034028770364 - ALADDIN-M: 2020-09-17