gudid Primary ID: "LDE4 02-2201"

TRANSTEK (UDI "LDE4 02-2201")

Manufactured by Sterilance Medical (Suzhou) Inc.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The TRANSTEK (Model/Catalog Number: "LDE4 02-2201") is a medical device manufactured by Sterilance Medical (Suzhou) Inc.. This product is indexed under FDA Product Code / Category Classification QRL within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: "LDE4 02-2201"
Product Code / EMDN: QRL
Device Name
Database Sync Date: 2026-08-09 09:11:03

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 TRANSTEK?

The registered manufacturer of record for TRANSTEK is Sterilance Medical (Suzhou) Inc..

What is the Primary UDI-DI identifier for TRANSTEK?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is "LDE4 02-2201".

What classification code is assigned to this device?

This device is registered under product classification code QRL.

Similar Classification Devices (QRL)

Other Devices by Sterilance Medical (Suzhou) Inc.

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