gudid Primary ID: AMS11-120-T

T-Edge 11 (UDI AMS11-120-T)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The T-Edge 11 (Model/Catalog Number: AMS11-120-T) is a medical device manufactured by TUTTNAUER ISRAEL LTD.. This product is indexed under FDA Product Code / Category Classification FLE within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: AMS11-120-T
Product Code / EMDN: FLE
Device Name: Sterilizer,steam
Database Sync Date: 2026-08-09 09:18:12

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 T-Edge 11?

The registered manufacturer of record for T-Edge 11 is TUTTNAUER ISRAEL LTD..

What is the Primary UDI-DI identifier for T-Edge 11?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is AMS11-120-T.

What classification code is assigned to this device?

This device is registered under product classification code FLE.

Similar Classification Devices (FLE)

Other Devices by TUTTNAUER ISRAEL LTD.

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