SDX System (UDI V1.0)

Manufactured by DYN'R

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

Scannable UDI-DI Representation

Device Regulatory Overview

The SDX System (Model/Catalog Number: V1.0) is a medical device manufactured by DYN'R. This product is indexed under FDA Product Code / Category Classification LHN within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: V1.0
Product Code / EMDN: LHN
Device Name: Gating Module for IBA ProteusPlus
Database Sync Date: 2026-08-09 09:26:35

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 SDX System?

The registered manufacturer of record for SDX System is DYN'R.

What is the Primary UDI-DI identifier for SDX System?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is V1.0.

What classification code is assigned to this device?

This device is registered under product classification code LHN.

Similar Classification Devices (LHN)

Other Devices by DYN'R

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