GUDIDData
eudamed_udi Primary ID: 06975447582140

Unspecified Brand (UDI 06975447582140)

Manufactured by Igenesis(Shanghai)Co.,Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Unspecified Brand - Primary ID 06975447582140

Device Regulatory Overview

The Unspecified Brand (Model/Catalog Number: 106-0064-01) is a medical device manufactured by Igenesis(Shanghai)Co.,Ltd.. This product is indexed under FDA Product Code / Category Classification W0105041002 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
106-0064-01
Product Code / EMDN
W0105041002
Device Name
Nucleic Acid Detection Kit for 16&18 Human Papillomavirus (HPV) Genotypes (PCR fluorescence probe method)
Database Sync Date
2026-08-09 16:30:28

Full Regulatory Attributes

🔒 Token Gated
{
    "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 Unspecified Brand?

The registered manufacturer of record for Unspecified Brand is Igenesis(Shanghai)Co.,Ltd..

What is the Primary UDI-DI identifier for Unspecified Brand?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06975447582140.

What classification code is assigned to this device?

This device is registered under product classification code W0105041002.

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