Element™Plus Meter

FDA UDI

Class II (US FDA UDI)

by OSANG HEALTHCARE Co., Ltd.

Identity

Trade Name: Element™Plus Meter FDA UDI
Generic Name: Glucose monitoring system IVD, home-use FDA UDI
Device Name: Blood Glucose Monitoring System FDA UDI
Model / Reference: IGM-0021B FDA UDI
Description: Blood Glucose Monitoring System FDA UDI

Identifiers

Primary DI / UDI-DI: 08809115908971 FDA UDI
510(k) Number: K103021 FDA UDI
FDA Product Code: CGA FDA UDI
NBW FDA UDI
JJX 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
862.1660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

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

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 0.3 Microliter FDA UDI

Category: Glucose monitoring system IVD, home-use

Element™Plus Meter by OSANG HEALTHCARE Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glucose monitoring system IVD, home-use.

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TRUE METRIX GO — TRIVIDIA HEALTH, INC. · Class II
Medline — MEDLINE INDUSTRIES, INC. · Class II
ReliOn® Confirm/micro Blood Glucose Test Strips — Walmart Stores · Class II
CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC. · Class II
LEADER — Cardinal Health 110, Inc. · Class II
CareSens N Voice Multi — i-SENS, Inc. · Class II

Cleared under the same submission

K103021 also covers:

Element™Plus Test Strips — OSANG HEALTHCARE Co., Ltd.

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: OSANG HEALTHCARE Co., Ltd.

Sources (1)

FDA UDI 83ee92e7-3d8b-450d-a78f-6ceb709eb5f5 37 fields · synced May 31, 2026