GUDIDData
eudamed_udi Primary ID: 06958982140648

One Step K2 Test (UDI 06958982140648)

Manufactured by Abiores Technology (Beijing) Co.,Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for One Step K2 Test - Primary ID 06958982140648

Device Regulatory Overview

The One Step K2 Test (Model/Catalog Number: AD25-11) is a medical device manufactured by Abiores Technology (Beijing) Co.,Ltd.. This product is indexed under FDA Product Code / Category Classification W0102160599 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
AD25-11
Product Code / EMDN
W0102160599
Device Name
One Step K2 Test
Database Sync Date
2026-08-09 16:30:43

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 One Step K2 Test?

The registered manufacturer of record for One Step K2 Test is Abiores Technology (Beijing) Co.,Ltd..

What is the Primary UDI-DI identifier for One Step K2 Test?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06958982140648.

What classification code is assigned to this device?

This device is registered under product classification code W0102160599.

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