eudamed_udi Primary ID: 06945040106432

SPIROMETER (UDI 06945040106432)

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 SPIROMETER (Model/Catalog Number: SP80B) is a medical device manufactured by Contec Medical Systems Co., Ltd.. This product is indexed under FDA Product Code / Category Classification Z12150101 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: SP80B
Product Code / EMDN: Z12150101
Device Name: SPIROMETER
Database Sync Date: 2026-08-09 16:47:59

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 SPIROMETER?

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

What is the Primary UDI-DI identifier for SPIROMETER?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06945040106432.

What classification code is assigned to this device?

This device is registered under product classification code Z12150101.

Similar Classification Devices (Z12150101)

Other Devices by Contec Medical Systems Co., Ltd.

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