Lapsi Health Holding B.V.
Active in EUDAMEDNetherlandsfrom SRN EUDAMED SRN NL-MF-000056311
- Devices
- 3
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Lapsi Health Holding B.V. makes
Lapsi Health Holding B.V. manufactures the Keikku Electronic Stethoscope, a digital diagnostic tool designed for auscultation in clinical settings. The device converts acoustic signals into electronic data, enabling enhanced audio capture and storage for medical evaluation.
The Keikku Electronic Stethoscope is classified as a Class II medical device under FDA regulations and has undergone 510(k) clearance. The company is based in the United States, with its product listed in the FDA’s 510(k) registry.
Catalogue
- Regimes: CE MDR Registry: EUDAMED
- Registry: GUDID
Keikku Electronic stethoscope Ref K233313
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- NL-MF-000056311
- DUNS number
- 494111993
- EU VAT number
- 85221244
- EUDAMED status
- Active
- EUDAMED registered name
- Lapsi Health Holding B.V
- Registered address
- 301, Science Park, 1098 XH, Amsterdam, Netherlands
- Website
- keikku.health/
- [email protected]
- Phone
- +358 40 6484534
- PRRC contact
- Katja Koskinen
Frequently asked questions
How many devices does Lapsi Health Holding B.V. have in the registry?
The registry currently lists 3 devices for Lapsi Health Holding B.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lapsi Health Holding B.V.'s devices?
Among its 3 most recently registered devices, Lapsi Health Holding B.V. has devices listed in EUDAMED (1 device), FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Lapsi Health Holding B.V.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Lapsi Health Holding B.V.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Lapsi Health Holding B.V. in the registry?
The most recently registered devices listed for Lapsi Health Holding B.V. include Keikku Scribe, Keikku Digital Stethoscope KEIKKUGEN1 and Keikku Electronic stethoscope.