GUDIDData
eudamed_udi Primary ID: 06950617403005

Unspecified Brand (UDI 06950617403005)

Manufactured by Maccura Biotechnology Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Unspecified Brand - Primary ID 06950617403005

Device Regulatory Overview

The Unspecified Brand (Model/Catalog Number: IM4414257) is a medical device manufactured by Maccura Biotechnology Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0102100112 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
IM4414257
Product Code / EMDN
W0102100112
Device Name
Anti-SSA(Ro52) Antibody Chemiluminescent Immunoassay Kit
Database Sync Date
2026-08-09 16:47:02

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 Maccura Biotechnology 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 06950617403005.

What classification code is assigned to this device?

This device is registered under product classification code W0102100112.

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