Asclea GmbH
Active in EUDAMEDGermanyfrom SRN EUDAMED SRN DE-MF-000007826
- Devices
- 1
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
x-cardiac-platform Ref REF1
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- DE-MF-000007826
- EU VAT number
- DE341411794
- EUDAMED status
- Active
- EUDAMED registered name
- Asclea GmbH
- Registered address
- 57, Kurfürstendamm, 10707, Berlin, Germany
- Website
- www.asclea.ai
- [email protected]
- PRRC contact
- Jürgen Wieser
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 19 Sep 2029
Notified body 0633 1 certificate
- Z-22-151-S-IX Active
Quality management system EU MDR
- Issued
- 14 Oct 2025
- Expires
- 19 Sep 2029
From the company website
Souveräne KI für Krankenhäuser. Foundation Model Hub heute. ChatEHR Ende 2026. Agentic Cockpit 2027.
Frequently asked questions
How many devices does Asclea GmbH have in the registry?
The registry currently lists 1 device for Asclea GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Asclea GmbH's devices?
Among its 1 most recently registered device, Asclea GmbH has devices listed in EUDAMED (1 device).
What risk classes do Asclea GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Asclea GmbH's devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Asclea GmbH?
EUDAMED lists 1 certificate for Asclea GmbH (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2025-10-14.
What are the newest devices from Asclea GmbH in the registry?
The most recently registered devices listed for Asclea GmbH include x-cardiac-platform.