eudamed_udi Primary ID: D-IM4402158J2

Unspecified Brand (UDI D-IM4402158J2)

Manufactured by Maccura Biotechnology Co., Ltd.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Unspecified Brand (Model/Catalog Number: IM4402158) is a medical device manufactured by Maccura Biotechnology Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W01021301 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: IM4402158
Product Code / EMDN: W01021301
Device Name: BNP Chemiluminescent Immunoassay Kit
Database Sync Date: 2026-08-09 16:45:41

Full Regulatory Attributes

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{
    "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 D-IM4402158J2.

What classification code is assigned to this device?

This device is registered under product classification code W01021301.

Similar Classification Devices (W01021301)

Other Devices by Maccura Biotechnology Co., Ltd.

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