eudamed_udi
Primary ID: 00860009117716
Garmin ECG App (UDI 00860009117716)
Manufactured by Garmin International, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Garmin ECG App - Primary ID 00860009117716
Device Regulatory Overview
The Garmin ECG App (Model/Catalog Number: Watch ECG App Component) is a medical device manufactured by Garmin International, Inc.. This product is indexed under FDA Product Code / Category Classification Z12050392 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Watch ECG App Component
- Product Code / EMDN
- Z12050392
- Device Name
- Garmin ECG App
- Database Sync Date
- 2026-08-09 18:09:33
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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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Garmin ECG App?
The registered manufacturer of record for Garmin ECG App is Garmin International, Inc..
What is the Primary UDI-DI identifier for Garmin ECG App?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00860009117716.
What classification code is assigned to this device?
This device is registered under product classification code Z12050392.
Similar Classification Devices (Z12050392)
Other Devices by Garmin International, Inc.
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