GUDIDData
eudamed_udi Primary ID: 09351179001505

EasyScreen (UDI 09351179001505)

Manufactured by Genetic Signatures Ltd

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for EasyScreen - Primary ID 09351179001505

Device Regulatory Overview

The EasyScreen (Model/Catalog Number: PE001H-MT) is a medical device manufactured by Genetic Signatures Ltd. This product is indexed under FDA Product Code / Category Classification W0105070504 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
PE001H-MT
Product Code / EMDN
W0105070504
Device Name
EasyScreen™ Pan-Enteric Pathogen Detection Kit (PE001)
Database Sync Date
2026-08-09 16:50:41

Full Regulatory Attributes

đź”’ 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 EasyScreen?

The registered manufacturer of record for EasyScreen is Genetic Signatures Ltd.

What is the Primary UDI-DI identifier for EasyScreen?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 09351179001505.

What classification code is assigned to this device?

This device is registered under product classification code W0105070504.

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