eudamed_udi Primary ID: 03700546710261

Withings ScanWatch 2 (UDI 03700546710261)

Manufactured by Withings

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Withings ScanWatch 2 (Model/Catalog Number: hwa10-39-silver) is a medical device manufactured by Withings. This product is indexed under FDA Product Code / Category Classification Z12040199 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-1280-2023 View Full Alert →

Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturat...

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Technical Specifications

Model Number: hwa10-39-silver
Product Code / EMDN: Z12040199
Device Name: Withings ScanWatch 2
Database Sync Date: 2026-08-09 16:47:15

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Withings ScanWatch 2?

The registered manufacturer of record for Withings ScanWatch 2 is Withings.

What is the Primary UDI-DI identifier for Withings ScanWatch 2?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 03700546710261.

What classification code is assigned to this device?

This device is registered under product classification code Z12040199.

Similar Classification Devices (Z12040199)

Other Devices by Withings

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