GUDIDData
eudamed_udi Primary ID: 04260498562824

PC-ECG Option I1 (UDI 04260498562824)

Manufactured by Norav Medical GmbH

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for PC-ECG Option I1 - Primary ID 04260498562824

Device Regulatory Overview

The PC-ECG Option I1 (Model/Catalog Number: HASP-SW-K-I1-01) is a medical device manufactured by Norav Medical GmbH. This product is indexed under FDA Product Code / Category Classification Z12050192 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
HASP-SW-K-I1-01
Product Code / EMDN
Z12050192
Device Name
PC-ECG 1200 Series
Database Sync Date
2026-08-09 19:06:57

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 PC-ECG Option I1?

The registered manufacturer of record for PC-ECG Option I1 is Norav Medical GmbH.

What is the Primary UDI-DI identifier for PC-ECG Option I1?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04260498562824.

What classification code is assigned to this device?

This device is registered under product classification code Z12050192.

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