Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012828634

FEI Number

3012828634

Entity Name

VISIONFLEX PTY LIMITED

City/State/Country

Sydney New South Wales, AU

Establishment Address

1/8 Prosperity Parade Warriewood, Sydney New South Wales 2102, AU

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Visionflex Pty Limited (Owner Number: 10051656)

Owner / Operator Contact Address

1/8 Prosperity Parade Warriewood, Sydney, AU-NSW 2102, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

General Exam Camera

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FWL	Camera, Cine, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2017-07-26

Official Correspondent

Mike Harman

US Agent Details

Brenda McGivern Business: Brenda J McGivern PC Email: brenda@bmcgiverncpa.com Phone: (781) 3410930

Related Public Records

Same Entity

Visionflex Pty Limited

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 3012828634. Last updated year: 2026. Please use registration number 3012828634 when referencing this establishment in official correspondence.