Data / Medical devices / Australia / Primex Medical Pty Ltd
Primex Medical Pty Ltd: FDA-registered device maker in Wembley Western Australia, Australia, 1 PMA approval
Primex Medical Pty Ltd is registered with the FDA (registration 3040678329) in Wembley Western Australia, Australia. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated February 11, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3040678329
- Address
- 56 Daglish St, Wembley Western Australia, Australia, 6014
- Owner or operator
- PrimeX Medical Pty Ltd (10094145)
- Roles
- Exporter to the US
- First device listed
- November 17, 2025
- Registered through
- 2026
- Brand names listed
- ; 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, Hologic Selenia Dimensions, GE Senographe Pristina, Siemens MAMMOMAT Revelation, Fujifilm Amulet Innovality ;, Radrex-i, Ultimax-i (fluoroscopy + X-ray) ; GE Voluson E10, Philips EPIQ 7, Siemens ACUSON Sequoia, Canon Aplio i700, Siemens Healthineers Ysio Max, Multix Impact ; Philips Healthcare DigitalDiagnost C90, ProGrade, Canon Medical
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Digital Breast Tomosynthesis | OTE | 3 | Exporter to the US | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 11, 2011 | P080003 | SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | OTE | 10 | November 24, 2025 | accessdata.fda.gov |
Compare with other makers
Updated November 24, 2025. 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.