Identity
- Trade Name
- ScaAI Patch EUDAMEDScaAI Patch Device EUDAMED
- Device Name
- ScaAI Patch Device EUDAMED
- Model / Reference
- 1007-L EUDAMEDSC-100-07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640375610041 EUDAMED07640375610058 EUDAMED
- Basic UDI-DI
- B-07640375610041 EUDAMEDB-07640375610058 EUDAMED
- EMDN Code
- C900399 CARDIOVASCULAR SENSORS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ScaAI Patch by SmartCardia SA — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07640375610041 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SmartCardia SA
- EUDAMED SRN
- CH-MF-000030647
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED d1d28364-4389-4fc9-afb2-a74a0b512bd3 61 fields · synced Jul 12, 2026
- EUDAMED c83619d0-6d7b-4bbd-b958-fd76d8728c89 61 fields · synced May 18, 2026