FDA Registration
Inactive
🇦🇺 Australia
ORECCHIO PTY LTD.
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ORECCHIO PTY LTD.
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit 2 & 3, 1 Centro Avenue
- City
- Subiaco Western Australia
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K221064
Owner / Operator
- Firm Name
- Orecchio Pty Ltd.
- Operator Number
- 10093625
- Address
- Unit 2 & 3, 1 Centro Avenue
- City
- Subiaco
- State
- Western Australia
- Postal Code
- 6008
- Country
- AU
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177 ext. 200
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Self-Fitting Air-Conduction Hearing Aid, Over The Counter | QUH | Class 2 | Ear, Nose, Throat | No | 2025-06-13 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device