Glucheck Self-Monitoring Blood Glucose System

GUDID 07506555400003

1 blood glucose meter; 1 CR2032 battery, 1 manual. 1 logbook in a convenience kit.

EPS BIO TECHNOLOGY CORP.

Glucose monitoring system IVD, home-use

• Primary Device ID: 07506555400003
• NIH Device Record Key: 6bdb9c81-9b19-4b93-91e0-79c83d3c5801
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glucheck Self-Monitoring Blood Glucose System
• Version Model Number: EasyMax T1 Pro
• Company DUNS: 658620117
• Company Name: EPS BIO TECHNOLOGY CORP.
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	07506555400003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102345

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

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: 2026-01-12
• Device Publish Date: 2026-01-02

Devices Manufactured by EPS BIO TECHNOLOGY CORP.

• 07506555400003 - Glucheck Self-Monitoring Blood Glucose System: 2026-01-121 blood glucose meter; 1 CR2032 battery, 1 manual. 1 logbook in a convenience kit.
• 07506555400003 - Glucheck Self-Monitoring Blood Glucose System: 2026-01-12 1 blood glucose meter; 1 CR2032 battery, 1 manual. 1 logbook in a convenience kit.
• 27506555400014 - Glucheck Blood Glucose Test Strip: 2026-01-12 25 strips in a vial x 2
• 00885017000409 - EASYMAX T1 Self-Monitoring Blood Glucose System: 2024-08-12 1 blood glucose meter; 25 ct. Foiled Pack Test Strips; 10 Lancets, 1 Lancing device in a convenience kit.
• 10885017000260 - FortisCare Blood Glucose Test Strip: 2021-04-26 25 strips in a vial.
• 10885017000277 - 25 EasyMax FTS Set EN-ES: 2020-12-18 The EASY MAX Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples
• 10885017000284 - 25 EasyMax 15 FTS Set EN-ES: 2020-12-18 The EASY MAX 15 Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samp
• 10885017000550 - EasyMax NHCS Set EN: 2020-07-01 1 bottle of Level 2 Solution
• 10885017000567 - EasyMax 15 NHCS Set EN: 2020-07-01 a bottle of level 2 control solution