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Withings Body Smart
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref WBS13-Black-All-Inter
by Withings
Identity
- Trade Name
- Withings Body Smart EUDAMEDWithings® FDA UDI
- Generic Name
- Bioelectrical body composition analyser FDA UDI
- Device Name
- Withings Smart Scales EUDAMED
- Model / Reference
- WBS13-Black-All-Inter EUDAMEDWBS13-Black FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700546708190 EUDAMEDFDA UDI
- Basic UDI-DI
- 3700546707957WS EUDAMED
- Direct Marketing DI
- 03700546708190 EUDAMED
- FDA Product Code
- PUH FDA UDI
- EMDN Code
- Z12062404 ELECTRODERMAL SIGNAL BIOFEEDBACK SYSTEMS EUDAMED
- GMDN Term
- Bioelectrical body composition analyser FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2770 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Withings Body Smart by Withings — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3700546707957WS | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Withings
- EUDAMED SRN
- FR-MF-000009505
Sources (2)
- EUDAMED 855ade43-94ed-4df6-97ba-f9f216221d3d 61 fields · synced Jul 9, 2026
- FDA UDI a61f434e-16ad-4abd-8afc-5977655a2094 32 fields · synced May 30, 2026