Data / Medical devices / Netherlands / Lapsi Health
Lapsi Health: FDA-registered device maker in Amsterdam Noord-Holland, Netherlands, 1 510(k) clearance
Lapsi Health is registered with the FDA (registration 3038129050) in Amsterdam Noord-Holland, Netherlands. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 10, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038129050
- Address
- Matrix One Unit 1. 53; Science Park 301, Amsterdam Noord-Holland, Netherlands, 1098 XH
- Owner or operator
- Lapsi Health (10092982)
- Roles
- Manufacturer
- First device listed
- March 13, 2025
- Registered through
- 2026
- Brand names listed
- Keikku
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stethoscope, Electronic | DQD | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| April 10, 2024 | K233313 | Keikku Electronic stethoscope | DQD | Substantially Equivalent | Lapsi Health Holding B.V. | accessdata.fda.gov |
Compare with other makers
Updated April 10, 2024. 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.