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GoCheck MultiScreener

FDA UDI

Class I (US FDA UDI)

by Gobiquity, Inc.

Identity

Trade Name
GoCheck MultiScreener FDA UDI
Generic Name
External ocular measurement camera FDA UDI
Device Name
GoCheck i7P MultiScreener Finished Device Assembly FDA UDI
Model / Reference
i7 Plus FDA UDI
Description
GoCheck i7P MultiScreener Finished Device Assembly FDA UDI

Identifiers

Primary DI / UDI-DI
B43071000020 FDA UDI
FDA Product Code
HKO FDA UDI
MMF FDA UDI
HOX FDA UDI
EWO 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
874.1050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tone audiometerVision testing/training chartExternal ocular measurement camera

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

Similar devices

Also classified as External ocular measurement camera.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gobiquity, Inc.

Sources (1)

  • FDA UDI 628d3331-efc0-42e4-9a48-9e4233485c4c 33 fields · synced May 31, 2026