EASYMAX T1 Self-Monitoring Blood Glucose System

FDA UDI

Class II (US FDA UDI)

by Eps Bio Technology Corp.

Identity

Trade Name: EASYMAX T1 Self-Monitoring Blood Glucose System FDA UDI
Generic Name: Glucose monitoring system IVD, home-use FDA UDI
Device Name: 1 blood glucose meter; 25 ct. Foiled Pack Test Strips; 10 Lancets, 1 Lancing device in a convenience kit. FDA UDI
Model / Reference: EasyMax T1 Pro FDA UDI
Description: 1 blood glucose meter; 25 ct. Foiled Pack Test Strips; 10 Lancets, 1 Lancing device in a convenience kit. FDA UDI

Identifiers

Primary DI / UDI-DI: 00885017000409 FDA UDI
510(k) Number: K102345 FDA UDI
FDA Product Code: NBW FDA UDI
GMDN Term: Glucose monitoring system IVD, home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1345 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Glucose monitoring system IVD, home-use

EASYMAX T1 Self-Monitoring Blood Glucose System by Eps Bio Technology Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Eps Bio Technology Corp.

Sources (1)

FDA UDI 0b6b5c80-eb75-47c1-b87b-4be80aee75b6 36 fields · synced May 31, 2026