Data / Medical devices / Netherlands / Sirius Medical Systems B.V.
Sirius Medical Systems B.V.: FDA-registered device maker in Eindhoven Noord-Brabant, Netherlands, 1 510(k) clearance
Sirius Medical Systems B.V. is registered with the FDA (registration 3020733550) in Eindhoven Noord-Brabant, Netherlands. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 9, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020733550
- Address
- High Tech Campus 41, Eindhoven Noord-Brabant, Netherlands, 5656AE
- Owner or operator
- Sirius Medical Systems B.V. (10082996)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 15, 2023
- Registered through
- 2026
- Brand names listed
- Sirius Pintuition Base Unit, Sirius Pintuition Probe, Sirius Pintuition Seed 12cm, Sirius Pintuition Seed 7cm, Sirius Pintuition Slim Probe, Sirius Pintuition Slim Test Kit, Sirius Pintuition Test Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Marker, Radiographic, Implantable | NEU | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Temporary Tissue Marker | PBY | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| November 9, 2023 | K223682 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | PBY | Substantially Equivalent | Sirius Medical Systems B.V. | accessdata.fda.gov |
Compare with other makers
Updated November 9, 2023. 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.