gudid
Primary ID: ECG100+
ECG100+ (UDI ECG100+)
Manufactured by CARDIOLINE SPA
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ECG100+ - Primary ID ECG100+
Device Regulatory Overview
The ECG100+ (Model/Catalog Number: ECG100+) is a medical device manufactured by CARDIOLINE SPA. This product is indexed under FDA Product Code / Category Classification DPS within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- ECG100+
- Product Code / EMDN
- DPS
- Device Name
- 12 lead high performance multichannel interpretative resting electrocardiograph which displays, acquires, prints and stores ECG tracings for adults and children 4,3 display and 100mm printer paper
- Database Sync Date
- 2026-08-09 09:04:28
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 ECG100+?
The registered manufacturer of record for ECG100+ is CARDIOLINE SPA.
What is the Primary UDI-DI identifier for ECG100+?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is ECG100+.
What classification code is assigned to this device?
This device is registered under product classification code DPS.
Similar Classification Devices (DPS)
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