eudamed_udi
Primary ID: 07290008960380
smartheart (UDI 07290008960380)
Manufactured by SHL Telemedicine International Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for smartheart - Primary ID 07290008960380
Device Regulatory Overview
The smartheart (Model/Catalog Number: E-XXX-X) is a medical device manufactured by SHL Telemedicine International Ltd.. This product is indexed under FDA Product Code / Category Classification Z12050803 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- E-XXX-X
- Product Code / EMDN
- Z12050803
- Device Name
- smartheart
- Database Sync Date
- 2026-08-09 17:55:00
Full Regulatory Attributes
π Token Gated
{
"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 smartheart?
The registered manufacturer of record for smartheart is SHL Telemedicine International Ltd..
What is the Primary UDI-DI identifier for smartheart?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 07290008960380.
What classification code is assigned to this device?
This device is registered under product classification code Z12050803.
Similar Classification Devices (Z12050803)
Other Devices by SHL Telemedicine International Ltd.
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