GUDIDData
eudamed_udi Primary ID: 04260498564286

ECG-USB1 (EX) (UDI 04260498564286)

Manufactured by Norav Medical GmbH

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ECG-USB1 (EX) - Primary ID 04260498564286

Device Regulatory Overview

The ECG-USB1 (EX) (Model/Catalog Number: ECGUSB1DEX-D-00-01) is a medical device manufactured by Norav Medical GmbH. This product is indexed under FDA Product Code / Category Classification Z12050301 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
ECGUSB1DEX-D-00-01
Product Code / EMDN
Z12050301
Device Name
PC-ECG 1200
Database Sync Date
2026-08-09 16:28:46

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of ECG-USB1 (EX)?

The registered manufacturer of record for ECG-USB1 (EX) is Norav Medical GmbH.

What is the Primary UDI-DI identifier for ECG-USB1 (EX)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04260498564286.

What classification code is assigned to this device?

This device is registered under product classification code Z12050301.

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