Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3039409159

FEI Number

3039409159

Entity Name

ORECCHIO PTY LTD.

City/State/Country

Subiaco Western Australia, AU

Establishment Address

Unit 2 & 3, 1 Centro Avenue, Subiaco Western Australia 6008, AU

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Orecchio Pty Ltd. (Owner Number: 10093625)

Owner / Operator Contact Address

Unit 2 & 3, 1 Centro Avenue, Subiaco, AU-WA 6008, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221064

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QUH	Self-Fitting Air-Conduction Hearing Aid, Over The Counter	Ear, Nose, Throat	Class 2	874.3325	2025-06-13

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Orecchio Pty 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 3039409159. Last updated year: 2026. Please use registration number 3039409159 when referencing this establishment in official correspondence.