Harmony Referral System

GUDID 06430078740005

Harmony is a web-based software solution that connects all examination instruments, eye care professionals, and the latest technologies to ensure the best possible patient care and customer experience.

Topcon Healthcare Solutions EMEA Oy

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Primary Device ID06430078740005
NIH Device Record Keye24f6b5e-e926-43ee-819f-817b389fd142
Commercial Distribution StatusIn Commercial Distribution
Brand NameHarmony Referral System
Version Model Number3.8.1
Company DUNS368366674
Company NameTopcon Healthcare Solutions EMEA Oy
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106430078740005 [Primary]

FDA Product Code

NFJSystem, Image Management, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-30
Device Publish Date2023-08-22

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