GUDIDData
eudamed_udi Primary ID: 06958066414153

Holter (UDI 06958066414153)

Manufactured by Suzhou Beneware Medical Equipment Co.,Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Holter - Primary ID 06958066414153

Device Regulatory Overview

The Holter (Model/Catalog Number: CT-082-EN) is a medical device manufactured by Suzhou Beneware Medical Equipment Co.,Ltd.. This product is indexed under FDA Product Code / Category Classification Z12050403 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
CT-082-EN
Product Code / EMDN
Z12050403
Device Name
Digital Holter Analysis Systems
Database Sync Date
2026-08-09 16:45:50

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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Frequently Asked Questions

Who is the primary manufacturer of Holter?

The registered manufacturer of record for Holter is Suzhou Beneware Medical Equipment Co.,Ltd..

What is the Primary UDI-DI identifier for Holter?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06958066414153.

What classification code is assigned to this device?

This device is registered under product classification code Z12050403.

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