GUDIDData
eudamed_udi Primary ID: 06933291710041

FX 80 (UDI 06933291710041)

Manufactured by Fresenius Medical Care (Jiangsu) Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for FX 80 - Primary ID 06933291710041

Device Regulatory Overview

The FX 80 (Model/Catalog Number: CN0218) is a medical device manufactured by Fresenius Medical Care (Jiangsu) Co., Ltd.. This product is indexed under FDA Product Code / Category Classification F01060303 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
CN0218
Product Code / EMDN
F01060303
Device Name
FX class dialyzers
Database Sync Date
2026-08-09 16:30:04

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 FX 80?

The registered manufacturer of record for FX 80 is Fresenius Medical Care (Jiangsu) Co., Ltd..

What is the Primary UDI-DI identifier for FX 80?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06933291710041.

What classification code is assigned to this device?

This device is registered under product classification code F01060303.

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