eudamed_udi Primary ID: 06945040105398

Pocket Fetal Doppler (UDI 06945040105398)

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 Pocket Fetal Doppler (Model/Catalog Number: CONTEC10B) is a medical device manufactured by Contec Medical Systems Co., Ltd.. This product is indexed under FDA Product Code / Category Classification Z12080103 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 →

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Technical Specifications

Model Number: CONTEC10B
Product Code / EMDN: Z12080103
Device Name: Pocket Fetal Doppler
Database Sync Date: 2026-08-09 16:47:00

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 Pocket Fetal Doppler?

The registered manufacturer of record for Pocket Fetal Doppler is Contec Medical Systems Co., Ltd..

What is the Primary UDI-DI identifier for Pocket Fetal Doppler?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06945040105398.

What classification code is assigned to this device?

This device is registered under product classification code Z12080103.

Similar Classification Devices (Z12080103)

Other Devices by Contec Medical Systems Co., Ltd.

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