gudid Primary ID: Belt/Bra accessory

actiTENS (UDI Belt/Bra accessory)

Manufactured by SUBLIMED

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

Scannable UDI-DI Representation

Device Regulatory Overview

The actiTENS (Model/Catalog Number: Belt/Bra accessory) is a medical device manufactured by SUBLIMED. This product is indexed under FDA Product Code / Category Classification GZJ within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: Belt/Bra accessory
Product Code / EMDN: GZJ
Device Name: The EIG can be held on the patients body using a belt/bra accessory close to the area to be stimulated. The belt/bra accessory is composed on its upper side of velvet VELCRO allowing the fixation of the EIG. They are reusable and machine washable by following the instructions on the instructions for use.
Database Sync Date: 2026-08-09 09:33:50

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 actiTENS?

The registered manufacturer of record for actiTENS is SUBLIMED.

What is the Primary UDI-DI identifier for actiTENS?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Belt/Bra accessory.

What classification code is assigned to this device?

This device is registered under product classification code GZJ.

Similar Classification Devices (GZJ)

Other Devices by SUBLIMED

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