Harmony Referral System

GUDID 06430078740272

Topcon Healthcare Solutions EMEA Oy

Medical image management system

• Primary Device ID: 06430078740272
• NIH Device Record Key: de1e9e42-aa9d-4e79-a490-6e2fcd84b8cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harmony Referral System
• Version Model Number: 3.10.0
• 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: true
• Serial Number: false
• 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	06430078740272 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210396

FDA Product Code

• NFJ: System, Image Management, Ophthalmic

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: 2025-08-15
• Device Publish Date: 2025-08-07

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
• 06430078740272: 3.10.0