Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022518366

FEI Number

3022518366

Entity Name

PainChek Ltd.

City/State/Country

Sydney New South Wales, AU

Establishment Address

Suite 401, 35 Lime Street, Sydney New South Wales 2000, AU

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

PainChek Ltd. (Owner Number: 10094224)

Owner / Operator Contact Address

Suite 401, 35 Lime Street, Sydney, AU-NSW 2000, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN240073

PMA Number

N/A

All Registered Proprietary Names

PainChek Adult

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SGB	Pain Assessment Software In Non-Communicative Adults	Neurology	Class 2	882.1472	2025-11-19

Official Correspondent

Caleb Ng

US Agent Details

Emily Matorin Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

PainChek Ltd.

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 3022518366. Last updated year: 2026. Please use registration number 3022518366 when referencing this establishment in official correspondence.