GUDIDData
gudid Primary ID: GEN-CK R2

GENCHEM CK-NAC Reagent (UDI GEN-CK R2)

Manufactured by GENCHEM INC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for GENCHEM CK-NAC Reagent - Primary ID GEN-CK R2

Device Regulatory Overview

The GENCHEM CK-NAC Reagent (Model/Catalog Number: GEN-CK R2) is a medical device manufactured by GENCHEM INC. This product is indexed under FDA Product Code / Category Classification CGS within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
GEN-CK R2
Product Code / EMDN
CGS
Device Name
10/17/2022
Database Sync Date
2026-08-09 09:49:36

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 GENCHEM CK-NAC Reagent?

The registered manufacturer of record for GENCHEM CK-NAC Reagent is GENCHEM INC.

What is the Primary UDI-DI identifier for GENCHEM CK-NAC Reagent?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is GEN-CK R2.

What classification code is assigned to this device?

This device is registered under product classification code CGS.

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