GLUCOCARD® Shine XL Blood Glucose Monitoring System

FDA UDI

Class II (US FDA UDI)

by Arkray Usa, Inc.

Identity

Trade Name: GLUCOCARD® Shine XL Blood Glucose Monitoring System FDA UDI
Generic Name: Glucose monitoring system IVD, home-use FDA UDI
Device Name: The GLUCOCARD Shine XL Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf. FDA UDI
Model / Reference: 542110 FDA UDI
Description: The GLUCOCARD Shine XL Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf. FDA UDI

Identifiers

Primary DI / UDI-DI: 00015482542108 FDA UDI
510(k) Number: K083468 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Glucose monitoring system IVD, home-use

GLUCOCARD® Shine XL Blood Glucose Monitoring System by Arkray Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K083468 also covers:

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: Arkray Usa, Inc.

Sources (1)

FDA UDI 83dd5e77-622f-4ddb-b6fc-22865cf26512 36 fields · synced Jun 1, 2026