GoCheck Kids

FDA UDI

Class I (US FDA UDI)

by Gobiquity, Inc.

Identity

Trade Name: GoCheck Kids FDA UDI
Generic Name: External ocular measurement camera FDA UDI
Device Name: Photoscreener with Flash Concentrator, mobile platform (i.e., iPhone 7 Plus) and current GoCheck Kids software. FDA UDI
Model / Reference: V5 i7 PFC FDA UDI
Description: Photoscreener with Flash Concentrator, mobile platform (i.e., iPhone 7 Plus) and current GoCheck Kids software. FDA UDI

Identifiers

Primary DI / UDI-DI: B43060030010 FDA UDI
FDA Product Code: HKO FDA UDI
MMF FDA UDI
HOX FDA UDI
GMDN Term: External ocular measurement camera FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.1760 FDA UDI
886.1120 FDA UDI
886.1150 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: External ocular measurement camera

GoCheck Kids by Gobiquity, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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PanoCam™ PRO — VISUNEX MEDICAL SYSTEMS INC. · Class II
PanoCam™ LT — VISUNEX MEDICAL SYSTEMS INC. · Class II

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: Gobiquity, Inc.

Sources (1)

FDA UDI 79d9eda9-51f1-4796-bd44-ee8868f95448 33 fields · synced May 30, 2026