KR-1W Viewer

GUDID 04560126266071

TOPCON CORPORATION

Automated ophthalmic refractometer

• Primary Device ID: 04560126266071
• NIH Device Record Key: eb3c3275-56bc-41e5-ae9c-78af544b5bcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KR-1W Viewer
• Version Model Number: KR-1W Viewer
• Company DUNS: 690542881
• Company Name: TOPCON CORPORATION
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560126266071 [Primary]

FDA Product Code

• HKO: Refractometer, 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: 2022-09-08
• Device Publish Date: 2022-08-31

Devices Manufactured by TOPCON CORPORATION

• 04560126269102 - 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2): 2025-09-19
• 04571130283381 - AUTO KERATO-REFRACTOMETER KR-1: 2025-06-27
• 04571130283404 - AUTO KERATO-REFRACTOMETER KR-800PA: 2025-05-20
• 04560126268662 - SightPilot NAVi Controller SNi-1 COMPU VISION CV-5000 REFRACTION SYSTEM Chronos: 2025-05-09
• 04571130283367 - AUTO KERATO-REFRACTOMETER KR-800A: 2025-04-23
• 04560126268495 - SightPilot NAVi Contoller SNi-1 for COMPU VISION CV-5000: 2025-03-07
• 04560126268532 - COMPU VISION CV-5000: 2025-03-07
• 04560126268549 - COMPU VISION CV-5000: 2025-03-07