PRIMEX MEDICAL PTY LTD

FDA Device Registration & Listing · Wembley Western Australia, AU · Registration 3040678329

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3040678329
FEI Number
3040678329
Entity Name
PRIMEX MEDICAL PTY LTD
City/State/Country
Wembley Western Australia, AU
Establishment Address
56 Daglish St, Wembley Western Australia 6014, AU
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
PrimeX Medical Pty Ltd (Owner Number: 10094145)
Owner / Operator Contact Address
56 Daglish St, Wembley, AU-WA 6014, AU
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P080003

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OTE Digital Breast Tomosynthesis Unknown Class 3 N/A 2025-11-17

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

PrimeX Medical Pty Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-2219-2025 FUJIFILM Healthcare Americas Corporation 3
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

Similar Registrations

Registration Number Establishment Name Location
3008496839 EvERX PTY LTD Sydney New South Wales, AU
3003775006 FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office HANAMAKI-SHI Iwate, JP
3012127758 Siemens Healthcare Limited Oakville Ontario, CA
3013875850 M-SOLUTIONS INC. Tokyo, JP
3036666444 FUJITA CO., LTD. Chiyoda-ku Tokyo, JP
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3040678329. Last updated year: 2026. Please use registration number 3040678329 when referencing this establishment in official correspondence.
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