OKULO LIMITED

FDA Device Registration & Listing · Bristol, UK, Bristol, City of, GB · Registration 3038131813

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3038131813
FEI Number
3038131813
Entity Name
OKULO LIMITED
City/State/Country
Bristol, UK, Bristol, City of, GB
Establishment Address
17-19 Berkeley Square,, Bristol, UK, Bristol, City of BS8 1HB, GB
Establishment Type(s)
Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
OKKO Health Inc. (Owner Number: 10093091)
Owner / Operator Contact Address
131 Continental Dr, Suite 305, Newark, DE 19713, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

OKKO Health App OKKO Health App

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QTO Digital Visual Acuity Test Ophthalmic Class 1 886.1150 2025-03-31
QTW Digital Amsler Grid Ophthalmic Class 1 886.1330 2025-04-23

Official Correspondent

Stephanie Campbell

US Agent Details

Stephanie Campbell Business: OKKO Health Inc. (USA) Email: uma.shanmugam@okkohealth.com Phone: (801) 6733973

Related Public Records

Same Entity

OKKO Health Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038131813. Last updated year: 2026. Please use registration number 3038131813 when referencing this establishment in official correspondence.
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