GUDIDData
eudamed_udi Primary ID: 06978035540096

actiTENS ear electrode (UDI 06978035540096)

Manufactured by Dongguan Goochain Technology Co., Ltd

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for actiTENS ear electrode - Primary ID 06978035540096

Device Regulatory Overview

The actiTENS ear electrode (Model/Catalog Number: SBM7AC001) is a medical device manufactured by Dongguan Goochain Technology Co., Ltd. This product is indexed under FDA Product Code / Category Classification Z12062880 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
SBM7AC001
Product Code / EMDN
Z12062880
Device Name
actiTENS ear electrode
Database Sync Date
2026-08-09 17:11:59

Full Regulatory Attributes

🔒 Token Gated
{
    "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 actiTENS ear electrode?

The registered manufacturer of record for actiTENS ear electrode is Dongguan Goochain Technology Co., Ltd.

What is the Primary UDI-DI identifier for actiTENS ear electrode?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06978035540096.

What classification code is assigned to this device?

This device is registered under product classification code Z12062880.

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