Auto Ref-Topographer HRKT-1

GUDID 08800019600992

The Auto Ref-Topographer HRKT-1 measures the light reflected from the retina using an MLA (Micro Lens Array) to provide information on the refractive power of the eye, and measures the curvature of the cornea and its defects by measuring the size of the image reflected from the cornea and testing for dry eye.

Huvitz Co., Ltd.

Automated ophthalmic refractometer

• Primary Device ID: 08800019600992
• NIH Device Record Key: da16b88a-f5c6-48dc-a1ed-5771752b9b6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Auto Ref-Topographer HRKT-1
• Version Model Number: HRKT-1
• Company DUNS: 688154202
• Company Name: Huvitz Co., Ltd.
• 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: 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	08800019600992 [Primary]

FDA Product Code

• MMQ: Topographer, Corneal, 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: 2026-02-09
• Device Publish Date: 2026-01-30

Devices Manufactured by Huvitz Co., Ltd.

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• 08800019600992 - Auto Ref-Topographer HRKT-1: 2026-02-09The Auto Ref-Topographer HRKT-1 measures the light reflected from the retina using an MLA (Micro Lens Array) to provide information on the refractive power of the eye, and measures the curvature of the cornea and its defects by measuring the size of the image reflected from the cornea and testing for dry eye.
• 08800019600992 - Auto Ref-Topographer HRKT-1: 2026-02-09 The Auto Ref-Topographer HRKT-1 measures the light reflected from the retina using an MLA (Micro Lens Array) to provide informat
• 08800019601005 - Lilivis: 2025-09-16 The Huvitz Dental Intraoral Scanner(LS-100) is a dental 3D scanner intended to be used to digitally record topographical charact
• 08800019600794 - Huvitz Integrated Image Server HIIS-1: 2025-08-22 This software (HIIS-1) is a web-based software that can store, analyze, print and transmit the medical images and refraction dat
• 08800019600961 - OCTiX IntraOral Scanner: 2025-03-26 Huvitz Dental Intraoral Scanner OCT (LSO-100) is a dental 3D scanner intended to be used to digitally record topographical chara
• 00880019600961 - Lilivis SCAN OPTOMO: 2024-12-04 Huvitz Dental Intraoral Scanner OCT (LSO-100) is a dental 3D scanner intended to be used to digitally record topographical chara
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• 08800019600985 - Instrument Table CIT-4200: 2024-07-02 Instrument Table CIT-4200