Digital Chart HDC-9000 HDC-9000

GUDID 08800019600190

Digital Chart is a computerized chart presenting device that provides charts for refractive correction test and various functional tests

Huvitz Co., Ltd.

Vision testing/training chart

• Primary Device ID: 08800019600190
• NIH Device Record Key: 4a36a5c6-2181-41b3-8c4d-6587a7e80aba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digital Chart HDC-9000
• Version Model Number: HDC-9000
• Catalog Number: HDC-9000
• 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

Customer Support Contacts

• Phone: +82314289100
• Email: svc@huvitz.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800019600190 [Primary]

FDA Product Code

• HOX: Chart, Visual Acuity

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-22
• Device Publish Date: 2019-05-10

Devices Manufactured by Huvitz Co., Ltd.

• 08800019600787 - Optical Biometer HBM-1: 2023-10-26 The Optical Biometer HBM-1 is a medical device that optically measures eye components such as: *Axial length *Corneal curvature
• 08800019600916 - Digital Refractor HDR-7100P: 2023-09-01 The HUVITZ Digital Refractor HDR-7100P system is a computerized auto refractor used for subjective refraction by regarding the p
• 08800019600923 - Auto Ref/Keratometer HRK-8100A: 2023-09-01 Auto Ref/Keratometer HRK-8100A is intended to provide the information of Spherical, Cylindrical and Axis while measuring the ref
• 08800019600411 - Applanation Tonometer HT-5000: 2023-06-20 Applanation Tonometer HT-5000
• 08800019600435 - Non-contact Tonometer HNT-1P: 2023-06-20 Non-contact Tonometer HNT-1P
• 08800019600503 - Ref-Keratometer ERK-9100: 2023-06-20 Ref-Keratometer ERK-9100
• 08800019600558 - Auto Tono/Refracto/Kerato/Pachymeter HTR-1A: 2023-06-20 Auto Tono/Refracto/Kerato/Pachymeter HTR-1A
• 08800019600732 - Digital Chart HDC-9100N: 2023-06-20 Digital Chart HDC-9100N