Data / Medical devices / Netherlands / Philips Medical Systems Nederland B.V.
Philips Medical Systems Nederland B.V.: FDA-registered device maker in Best Noord-Brabant, Netherlands, 2 510(k) clearances
Philips Medical Systems Nederland B.V. is registered with the FDA (registration 3042175841) in Best Noord-Brabant, Netherlands. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 24, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3042175841
- Address
- Veenpluis 6, Best Noord-Brabant, Netherlands, 5684 PC
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Specification developer
- First device listed
- March 19, 2024
- Registered through
- 2026
- Brand names listed
- LumiGuide 3D Hub, LumiGuide Equipment R2, LumiGuide Equipment R2.1, LumiGuide Wire
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Specification developer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 24, 2025 | K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | DQK | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| March 14, 2024 | K233853 | LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub | DQK | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
Compare with other makers
Updated October 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.