ARK Care®

FDA UDI

Class I (US FDA UDI)

by Arkray Usa, Inc.

Identity

Trade Name: ARK Care® FDA UDI
Generic Name: Self-care monitoring/reporting software FDA UDI
Device Name: ARK Care is a Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the effectiveness of care and improve outcomes. FDA UDI
Model / Reference: Version 2.5.3. FDA UDI
Description: ARK Care is a Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the effectiveness of care and improve outcomes. FDA UDI

Identifiers

Primary DI / UDI-DI: 00015482000011 FDA UDI
510(k) Number: K110709 FDA UDI
FDA Product Code: JQP FDA UDI
GMDN Term: Self-care monitoring/reporting software FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2100 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

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Self-care monitoring/reporting software

ARK Care® by Arkray Usa, Inc. — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Arkray Usa, Inc.

Sources (1)

FDA UDI ff9a8ab1-677a-4527-b363-5cf814a2b3e8 35 fields · synced Jun 8, 2026