GUDIDData
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eudamed_udi Primary ID: 03700546708305

Withings ScanWatch 2 (UDI 03700546708305)

Manufactured by Withings

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Withings ScanWatch 2 - Primary ID 03700546708305

Device Regulatory Overview

The Withings ScanWatch 2 (Model/Catalog Number: hwa10-42-black-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
hwa10-42-black-silver
Product Code / EMDN
Z12040199
Device Name
Withings ScanWatch 2
Database Sync Date
2026-08-09 17:25:38

Full Regulatory Attributes

🔒 Token Gated 
{
    "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 03700546708305.

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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