FDA Registration
Active
🇦🇺 Australia
Philips Sectra MicroDose L30
Reg #: 3008496839
·
FEI: 3008496839
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- EvERX PTY LTD
- Registration Number
- 3008496839
- FEI Number
- 3008496839
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3 / 185 Briens Rd, Northmead
- City
- Sydney New South Wales
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K110025
Owner / Operator
- Firm Name
- EverX / Bindra
- Operator Number
- 10033159
- Address
- 3 / 185 Briens Rd, Northmead
- City
- Sydney
- State
- New South Wales
- Postal Code
- 2152
- Country
- AU
- Correspondent
- Ravinder S Bindra
US Agent
- Business Name
- EverX USA LLC
- Contact Name
- Hamish Dunn
- Address
- 2410 LA MIRADA DRIVE
- City
- Vista
- State
- CA
- ZIP
- 92081
- Country
- US
- [email protected]
- Phone
- 760 4297019
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Full Field Digital, System, X-Ray, Mammographic | MUE | Class 2 | Radiology | No | 2025-04-30 |
Proprietary Names
Philips Sectra MicroDose L30
Establishment Types
Export Device to the United States But Perform No Other Operation on Device