Data / Medical devices / Netherlands / Tromp Medical BV
Tromp Medical BV: FDA-registered device maker in Castricum Noord-Holland, Netherlands, 2 PMA approvals
Tromp Medical BV is registered with the FDA (registration 3008833258) in Castricum Noord-Holland, Netherlands. It lists 3 device types. The FDA files 2 PMA approvals 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
- 3008833258
- Address
- Oude Haarlemmerweg 75, Castricum Noord-Holland, Netherlands, 1901 ND
- Owner or operator
- Tromp Medical (10092743)
- Roles
- Exporter to the US
- First device listed
- February 13, 2025
- Registered through
- 2026
- Brand names listed
- Hologic Mammo 113T tube, Hologic Selenia Dimensions 3D Mammo, Hologic Selenia Dimensions Mammography
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assembly, Tube Housing, X-Ray, Diagnostic | ITY | 1 | Exporter to the US | accessdata.fda.gov |
| Digital Breast Tomosynthesis | OTE | 3 | Exporter to the US | accessdata.fda.gov |
| Full Field Digital, System, X-Ray, Mammographic | MUE | 2 | 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 |
| March 15, 2002 | P010025 | LORAD DIGITAL BREAST IMAGER | MUE | 17 | November 16, 2010 | accessdata.fda.gov |
Compare with other makers
- All makers of Assembly, Tube Housing, X-Ray, Diagnostic
- All makers of Digital Breast Tomosynthesis
- All makers of Full Field Digital, System, X-Ray, Mammographic
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.