gudid Primary ID: DZ05-A1

SimbR (UDI DZ05-A1)

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 SimbR (Model/Catalog Number: DZ05-A1) is a medical device manufactured by Contec Medical Systems Co., Ltd.. This product is indexed under FDA Product Code / Category Classification PGJ 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: DZ05-A1
Product Code / EMDN: PGJ
Device Name: Pulse Oximeter
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 SimbR?

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

What is the Primary UDI-DI identifier for SimbR?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is DZ05-A1.

What classification code is assigned to this device?

This device is registered under product classification code PGJ.

Similar Classification Devices (PGJ)

Other Devices by Contec Medical Systems Co., Ltd.

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