eudamed_udi Primary ID: 06955748410410

Hemodialysis Equipment (UDI 06955748410410)

Manufactured by SWS Hemodialysis Care Co.,Ltd.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Hemodialysis Equipment (Model/Catalog Number: SWS-4000A) is a medical device manufactured by SWS Hemodialysis Care Co.,Ltd.. This product is indexed under FDA Product Code / Category Classification Z12090201 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: SWS-4000A
Product Code / EMDN: Z12090201
Device Name: Hemodialysis Equipment
Database Sync Date: 2026-08-09 17:45:41

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 Hemodialysis Equipment?

The registered manufacturer of record for Hemodialysis Equipment is SWS Hemodialysis Care Co.,Ltd..

What is the Primary UDI-DI identifier for Hemodialysis Equipment?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06955748410410.

What classification code is assigned to this device?

This device is registered under product classification code Z12090201.

Similar Classification Devices (Z12090201)

Other Devices by SWS Hemodialysis Care Co.,Ltd.

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