Identity
- Trade Name
- Withings ECG Monitor 2 EUDAMED
- Device Name
- Withings ECG Monitor 2 EUDAMED
- Model / Reference
- ECGSW2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700546711442 EUDAMED
- Basic UDI-DI
- 3700546711442UM EUDAMED
- Direct Marketing DI
- 03700546711442 EUDAMED
- EMDN Code
- Z12050392 ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- France 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
Withings ECG Monitor 2 by Withings — Class IIa — 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 | 3700546711442UM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Withings
- EUDAMED SRN
- FR-MF-000009505
Sources (1)
- EUDAMED e156749d-7fa3-452a-ba1d-7330ab9302d1 61 fields · synced Jun 18, 2026