Data / Medical devices / Sweden / Neoventa Medical AB
Neoventa Medical AB: FDA-registered device maker in Molndal Vastra Gotaland, Sweden, 1 510(k) clearance
Neoventa Medical AB is registered with the FDA (registration 3004729605) in Molndal Vastra Gotaland, Sweden. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 17, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004729605
- FEI number
- 3005011303
- Address
- Norra Agatan 32, Molndal Vastra Gotaland, Sweden, 43135
- Owner or operator
- Neoventa Medical AB (10095143)
- Roles
- Specification developer
- First device listed
- January 28, 2026
- Registered through
- 2026
- Brand names listed
- Goldtrace Fetal Spiral Electrode (FSE)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Circular (Spiral), Scalp And Applicator | HGP | 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 |
|---|---|---|---|---|---|---|
| January 17, 2025 | K243291 | Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) | HGP | Substantially Equivalent | Neoventa Medical AB | accessdata.fda.gov |
Compare with other makers
Updated January 17, 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.