eudamed_udi
Primary ID: B2100020190
KardiaStation 12L (iOS) (UDI B2100020190)
Manufactured by AliveCor, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for KardiaStation 12L (iOS) - Primary ID B2100020190
Device Regulatory Overview
The KardiaStation 12L (iOS) (Model/Catalog Number: 002019) is a medical device manufactured by AliveCor, Inc.. This product is indexed under FDA Product Code / Category Classification Z12050392 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 002019
- Product Code / EMDN
- Z12050392
- Device Name
- KardiaStation 12L App
- Database Sync Date
- 2026-08-09 18:06:58
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 KardiaStation 12L (iOS)?
The registered manufacturer of record for KardiaStation 12L (iOS) is AliveCor, Inc..
What is the Primary UDI-DI identifier for KardiaStation 12L (iOS)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is B2100020190.
What classification code is assigned to this device?
This device is registered under product classification code Z12050392.
Similar Classification Devices (Z12050392)
Other Devices by AliveCor, Inc.
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