eudamed_udi Primary ID: 03700546708084

Withings ECG Monitor (UDI 03700546708084)

Manufactured by Withings

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Withings ECG Monitor (Model/Catalog Number: ECG-SW2) is a medical device manufactured by Withings. This product is indexed under FDA Product Code / Category Classification Z12050392 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...

🔒 Compromised Lot & Serial Numbers Locked

Verify if facility inventory is affected by this recall.

Unlock Lot Data ($49)

Technical Specifications

Model Number: ECG-SW2
Product Code / EMDN: Z12050392
Device Name: Withings ECG Monitor
Database Sync Date: 2026-08-09 16:55:35

Full Regulatory Attributes

🔒 Token Gated

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

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of Withings ECG Monitor?

The registered manufacturer of record for Withings ECG Monitor is Withings.

What is the Primary UDI-DI identifier for Withings ECG Monitor?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 03700546708084.

What classification code is assigned to this device?

This device is registered under product classification code Z12050392.

Similar Classification Devices (Z12050392)

Other Devices by Withings

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint