GUDIDData
eudamed_udi Primary ID: 00810186848514

Automatic Chemiluminescence Immunoassay Analyzer,Brand:Oupirou (UDI 00810186848514)

Manufactured by Acro Biotech Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Automatic Chemiluminescence Immunoassay Analyzer,Brand:Oupirou - Primary ID 00810186848514

Device Regulatory Overview

The Automatic Chemiluminescence Immunoassay Analyzer,Brand:Oupirou (Model/Catalog Number: ACA001) is a medical device manufactured by Acro Biotech Inc.. This product is indexed under FDA Product Code / Category Classification W0201020101 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
ACA001
Product Code / EMDN
W0201020101
Device Name
Fluorescence Immunoassay Analyzer
Database Sync Date
2026-08-09 16:47:22

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 Automatic Chemiluminescence Immunoassay Analyzer,Brand:Oupirou?

The registered manufacturer of record for Automatic Chemiluminescence Immunoassay Analyzer,Brand:Oupirou is Acro Biotech Inc..

What is the Primary UDI-DI identifier for Automatic Chemiluminescence Immunoassay Analyzer,Brand:Oupirou?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00810186848514.

What classification code is assigned to this device?

This device is registered under product classification code W0201020101.

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