FDA Registration
Active
🇦🇺 Australia
PRIMEX MEDICAL PTY LTD
Reg #: 3040678329
·
FEI: 3040678329
·
Expires 2026
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
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Registration Details
- Registration Name
- PRIMEX MEDICAL PTY LTD
- Registration Number
- 3040678329
- FEI Number
- 3040678329
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 56 Daglish St
- City
- Wembley Western Australia
- Country
- AU
Regulatory Submissions
- PMA Number
- P080003
Owner / Operator
- Firm Name
- PrimeX Medical Pty Ltd
- Operator Number
- 10094145
- Address
- 56 Daglish St
- City
- Wembley
- State
- Western Australia
- Postal Code
- 6014
- 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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Digital Breast Tomosynthesis | OTE | Class 3 | Unknown | No | 2025-11-17 |
Proprietary Names
Radrex-i, Ultimax-i (fluoroscopy + X-ray) ; GE Voluson E10, Philips EPIQ 7, Siemens ACUSON Sequoia, Canon Aplio i700
Hologic Selenia Dimensions, GE Senographe Pristina, Siemens MAMMOMAT Revelation, Fujifilm Amulet Innovality ;
; GE Revolution CT, Siemens SOMATOM Definition Flash, Philips Ingenuity CT
Canon Aquilion Prime ; Hologic Horizon DXA, GE Lunar iDXA GE Healthcare Optima XR646, Discovery XR656
Siemens Healthineers Ysio Max, Multix Impact ; Philips Healthcare DigitalDiagnost C90, ProGrade, Canon Medical
Establishment Types
Export Device to the United States But Perform No Other Operation on Device