GUDIDData
gudid Primary ID: Clinical

ISCUSflex (UDI Clinical)

Manufactured by M DIALYSIS INC.

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

Device Regulatory Overview

The ISCUSflex (Model/Catalog Number: Clinical) is a medical device manufactured by M DIALYSIS INC.. This product is indexed under FDA Product Code / Category Classification GWM within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
Clinical
Product Code / EMDN
GWM
Device Name
Microdialysis analyzer using substance specific reagents to evaluate the concentrations in the samples given by the Microdialysis sampling system (Catheter, 106 MD Pump and Microvials).
Database Sync Date
2026-08-09 09:10:27

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of ISCUSflex?

The registered manufacturer of record for ISCUSflex is M DIALYSIS INC..

What is the Primary UDI-DI identifier for ISCUSflex?

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

What classification code is assigned to this device?

This device is registered under product classification code GWM.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint