eudamed_udi Primary ID: 03770018808215

actiTENS (UDI 03770018808215)

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: SBM1AA008) is a medical device manufactured by sublimed. This product is indexed under FDA Product Code / Category Classification Z120601 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: SBM1AA008
Product Code / EMDN: Z120601
Device Name: actiTENS kit / actiTENS mini kit / coffret VitaliTENS/ coffret VitaliTENS mini
Database Sync Date: 2026-08-09 16:44:52

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 03770018808215.

What classification code is assigned to this device?

This device is registered under product classification code Z120601.

Similar Classification Devices (Z120601)

Other Devices by sublimed

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