GUDIDData
eudamed_udi Primary ID: 07350012440251

TetraSensitive (UDI 07350012440251)

Manufactured by Senzime AB

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for TetraSensitive - Primary ID 07350012440251

Device Regulatory Overview

The TetraSensitive (Model/Catalog Number: SEN 2016) is a medical device manufactured by Senzime AB. This product is indexed under FDA Product Code / Category Classification Z12062899 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
SEN 2016
Product Code / EMDN
Z12062899
Device Name
TetraSensitive
Database Sync Date
2026-08-09 17:17:43

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 TetraSensitive?

The registered manufacturer of record for TetraSensitive is Senzime AB.

What is the Primary UDI-DI identifier for TetraSensitive?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 07350012440251.

What classification code is assigned to this device?

This device is registered under product classification code Z12062899.

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