GUDIDData
eudamed_udi Primary ID: 06978465238136

Alpha-Fetoprotein Assay kit(Chemiluminescence Immunoassay Method) (UDI 06978465238136)

Manufactured by Shenzhen Dake Medical Technology Co.,Ltd

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Alpha-Fetoprotein Assay kit(Chemiluminescence Immunoassay Method) - Primary ID 06978465238136

Device Regulatory Overview

The Alpha-Fetoprotein Assay kit(Chemiluminescence Immunoassay Method) (Model/Catalog Number: 100 tests) is a medical device manufactured by Shenzhen Dake Medical Technology Co.,Ltd. This product is indexed under FDA Product Code / Category Classification W0102039001 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
100 tests
Product Code / EMDN
W0102039001
Device Name
Alpha-Fetoprotein Assay kit(Chemiluminescence Immunoassay Method)
Database Sync Date
2026-08-09 17:24:26

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 Alpha-Fetoprotein Assay kit(Chemiluminescence Immunoassay Method)?

The registered manufacturer of record for Alpha-Fetoprotein Assay kit(Chemiluminescence Immunoassay Method) is Shenzhen Dake Medical Technology Co.,Ltd.

What is the Primary UDI-DI identifier for Alpha-Fetoprotein Assay kit(Chemiluminescence Immunoassay Method)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06978465238136.

What classification code is assigned to this device?

This device is registered under product classification code W0102039001.

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