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Withings ECG Monitor
EUDAMEDClass IIa (EU MDR)
Ref ECG-SW2Model wbsecg
by Withings
Identity
- Trade Name
- Withings ECG Monitor EUDAMED
- Device Name
- Withings ECG Monitor EUDAMED
- Model / Reference
- wbsecg EUDAMEDECG-SW2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700546708084 EUDAMED
- Basic UDI-DI
- 3700546708084VP 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Withings ECG Monitor 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 | 3700546708084VP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Withings
- EUDAMED SRN
- FR-MF-000009505
Sources (1)
- EUDAMED d64f3d6f-15eb-49b6-8190-f521eb99dbdf 61 fields · synced Jun 19, 2026