Harmony Referral System

GUDID 06430078740265

Topcon Healthcare Solutions EMEA Oy

Medical image management system

• Primary Device ID: 06430078740265
• NIH Device Record Key: 99f2649c-61f4-42b5-ba0e-faae919fc2c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harmony Referral System
• Version Model Number: 3.9.1
• Company DUNS: 368366674
• Company Name: Topcon Healthcare Solutions EMEA Oy
• 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: true
• 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	06430078740265 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210396

FDA Product Code

• OUG: Medical Device Data System

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: 2024-05-23
• Device Publish Date: 2024-05-15

On-Brand Devices [Harmony Referral System]

• 06430078740005: Harmony is a web-based software solution that connects all examination instruments, eye care pro
• 06430078740265: 3.9.1