SmartCardia SA
Active in EUDAMEDSwitzerlandfrom SRN EUDAMED FDA SRN CH-MF-000030647 FEI 3029904429
SmartCardia SA is a medical device manufacturer based in Switzerland, with 4 devices listed in EUDAMED, FDA 510(k) and FDA GUDID (EU Class IIa; FDA Class II) as of 14 Nov 2026.
- Devices
- 4
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- EUDAMED 2
- FDA 510(k) 2
- FDA GUDID 2
- Device classes
- EU Class IIa 2
- FDA Class II 2
- Top EMDN categories
- Sites and related companies
- AR Experts B.V. authorised representative
- Identifiers
- EUDAMED SRN CH-MF-000030647
- FDA FEI 3029904429
- DUNS 487152899
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- AR Experts B.V.NL
What SmartCardia SA makes
SmartCardia SA manufactures medical devices for cardiac monitoring and diagnostics, including the SmartCardia 7L Platform for long-term electrocardiogram (ECG) recording and the ScaAI Patch for continuous cardiac rhythm analysis with AI-assisted interpretation.
The company’s portfolio includes Class II and Class IIa devices, with products listed in the EU’s EUDAMED registry and cleared via the FDA’s 510(k) pathway. The manufacturer is based in Switzerland.
Catalogue
SmartCardia 7L Platform (MCT) Ref K240653
Regimes: 510(k) Registry: 510(k)SmartCardia 7L Platform Ref K231276
Regimes: 510(k) Registry: 510(k)ScaAI Patch Device Ref SC-100-07
Regimes: CE MDD Registry: EUDAMEDGUDIDScaAI Patch Ref 1007-L
Regimes: CE MDD Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- CH-MF-000030647
- FDA FEI number
- 3029904429
- DUNS number
- 487152899
- EUDAMED status
- Active
- EUDAMED registered name
- SmartCardia SA
- Registered address
- EPFL Innovation Park, Bâtiment D, 1015, LAUSANNE, Switzerland
- Website
- www.smartcardia.com/
- PRRC contact
- NICEE SRIVASTAVA
Frequently asked questions
How many devices does SmartCardia SA have in the registry?
The registry currently lists 4 devices for SmartCardia SA. Devices recorded under merged duplicate company entries are counted once.
Which registries list SmartCardia SA's devices?
Among its 4 most recently registered devices, SmartCardia SA has devices listed in EUDAMED (2 devices), FDA 510(k) (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do SmartCardia SA's devices fall under?
Among its 4 most recently registered devices, the classes recorded for SmartCardia SA's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from SmartCardia SA in the registry?
The most recently registered devices listed for SmartCardia SA include SmartCardia 7L Platform (MCT), SmartCardia 7L Platform, ScaAI Patch Device and ScaAI Patch.