gudid
Primary ID: HD+12
HD+12 (UDI HD+12)
Manufactured by CARDIOLINE SPA
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HD+12 - Primary ID HD+12
Device Regulatory Overview
The HD+12 (Model/Catalog Number: HD+12) is a medical device manufactured by CARDIOLINE SPA. This product is indexed under FDA Product Code / Category Classification DRG within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- HD+12
- Product Code / EMDN
- DRG
- Device Name
- Digital portable acquisition device which can acquire the electrocardiographic signal of 12 standard leads. Connected with a receiver via Bluetooth or USB, sends the data to the host.
- Database Sync Date
- 2026-08-09 09:04:28
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 HD+12?
The registered manufacturer of record for HD+12 is CARDIOLINE SPA.
What is the Primary UDI-DI identifier for HD+12?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is HD+12.
What classification code is assigned to this device?
This device is registered under product classification code DRG.
Similar Classification Devices (DRG)
Other Devices by CARDIOLINE SPA
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint