GUDIDData
eudamed_udi Primary ID: 08684496893333

BIOFORCE (UDI 08684496893333)

Manufactured by LEDFIX ELEKTRONIK TICARET ANONIM SIRKETI

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for BIOFORCE - Primary ID 08684496893333

Device Regulatory Overview

The BIOFORCE (Model/Catalog Number: SM-01) is a medical device manufactured by LEDFIX ELEKTRONIK TICARET ANONIM SIRKETI. This product is indexed under FDA Product Code / Category Classification Z120601 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
SM-01
Product Code / EMDN
Z120601
Device Name
BIOFORCE TENS DEVICE
Database Sync Date
2026-08-09 16:50:17

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 BIOFORCE?

The registered manufacturer of record for BIOFORCE is LEDFIX ELEKTRONIK TICARET ANONIM SIRKETI.

What is the Primary UDI-DI identifier for BIOFORCE?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08684496893333.

What classification code is assigned to this device?

This device is registered under product classification code Z120601.

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