Identity
- Device Name
- ECG app EUDAMED
- Model / Reference
- ECG-V1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932554417604 EUDAMED06932554417611 EUDAMED
- Basic UDI-DI
- 69325544010101SR EUDAMED
- Direct Marketing DI
- 06932554417604 EUDAMED06932554417611 EUDAMED
- EMDN Code
- Z12050392 ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Ireland 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ECG app by Xiaomi Communications Co., Ltd. — 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 | 69325544010101SR | Class IIb | Active |
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Manufacturer
- Manufacturer
- Xiaomi Communications Co., Ltd.
- EUDAMED SRN
- CN-MF-000046125
- Authorised Representative
- BioDomi GmbH DE-AR-000016611
Sources (2)
- EUDAMED 921caea1-99fc-409a-8fe0-d770df9ea1d2 61 fields · synced Jul 30, 2026
- EUDAMED cdd72532-39b9-4576-b0da-d593306838cd 61 fields · synced May 19, 2026