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Withings BeamO
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref SCT02-02Model SCT02Ref SCT02-03
by Withings
Identity
- Device Name
- Withings BeamO EUDAMED
- Model / Reference
- SCT02 EUDAMEDSCT02-02 EUDAMEDSCT02-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700546710209 EUDAMED03700546709937 EUDAMED
- Basic UDI-DI
- 3700546709937X2 EUDAMED
- Direct Marketing DI
- 03700546710209 EUDAMED03700546709937 EUDAMED
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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 BeamO by Withings — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252474 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 3700546709937X2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Withings
- EUDAMED SRN
- FR-MF-000009505
Sources (3)
- EUDAMED 0d98047c-6ce3-4575-bfd5-94c757f772a7 61 fields · synced Jul 24, 2026
- EUDAMED 2a465874-84e2-4c64-8c00-8a2a7dddc0a5 61 fields · synced May 17, 2026
- FDA 510(k) K252474 1 fields · synced May 18, 2026