Data / Medical devices / Australia / Orecchio Pty Ltd.
Orecchio Pty Ltd.: FDA-registered device maker in Subiaco Western Australia, Australia, 1 510(k) clearance
Orecchio Pty Ltd. is registered with the FDA (registration 3039409159) in Subiaco Western Australia, Australia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 30, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3039409159
- Address
- Unit 2 & 3, 1 Centro Avenue, Subiaco Western Australia, Australia, 6008
- Owner or operator
- Orecchio Pty Ltd. (10093625)
- Roles
- Manufacturer, Specification developer
- First device listed
- June 13, 2025
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Self-Fitting Air-Conduction Hearing Aid, Over The Counter | QUH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 30, 2022 | K221064 | Nuheara IQbuds 2 PRO Hearing Aid | QUH | Substantially Equivalent | Nuheara Limited | accessdata.fda.gov |
Compare with other makers
Updated October 30, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.