eudamed_udi Primary ID: 06970150909017

hs-CRP CLIA Microparticles (UDI 06970150909017)

Manufactured by Autobio Diagnostics Co., Ltd.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The hs-CRP CLIA Microparticles (Model/Catalog Number: CMR0102) is a medical device manufactured by Autobio Diagnostics Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W01021109 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: CMR0102
Product Code / EMDN: W01021109
Device Name: AutoLumo analyzer
Database Sync Date: 2026-08-09 16:28:44

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 hs-CRP CLIA Microparticles?

The registered manufacturer of record for hs-CRP CLIA Microparticles is Autobio Diagnostics Co., Ltd..

What is the Primary UDI-DI identifier for hs-CRP CLIA Microparticles?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06970150909017.

What classification code is assigned to this device?

This device is registered under product classification code W01021109.

Similar Classification Devices (W01021109)

Other Devices by Autobio Diagnostics Co., Ltd.

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