gudid Primary ID: BC3000

CONTEC (UDI BC3000)

Manufactured by Contec Medical Systems Co., Ltd.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The CONTEC (Model/Catalog Number: BC3000) is a medical device manufactured by Contec Medical Systems Co., Ltd.. This product is indexed under FDA Product Code / Category Classification JJE within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-1764-2025 View Full Alert →

CMS8000 Patient Monitor...

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Technical Specifications

Model Number: BC3000
Product Code / EMDN: JJE
Device Name: Automatic Biochemistry Analyzer
Database Sync Date: 2026-08-09 09:11:04

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 CONTEC?

The registered manufacturer of record for CONTEC is Contec Medical Systems Co., Ltd..

What is the Primary UDI-DI identifier for CONTEC?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is BC3000.

What classification code is assigned to this device?

This device is registered under product classification code JJE.

Similar Classification Devices (JJE)

Other Devices by Contec Medical Systems Co., Ltd.

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