Identity
- Trade Name
- KardiaStation 12L (iOS) EUDAMED
- Device Name
- KardiaStation 12L App EUDAMED
- Model / Reference
- 002019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B2100020190 EUDAMED
- Basic UDI-DI
- ++B210KS12LS7 EUDAMED
- Direct Marketing DI
- B2100020190 EUDAMED
- EMDN Code
- Z12050392 ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
KardiaStation 12L (iOS) by AliveCor — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B210KS12LS7 | Class IIb | Active |
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Manufacturer
- Manufacturer
- AliveCor, Inc.
- EUDAMED SRN
- US-MF-000029146
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED aab1d28f-fa8d-4693-a670-28ecbaddee4f 61 fields · synced Jul 19, 2026