GUDIDData
gudid Primary ID: 12016687

Opus (UDI 12016687)

Manufactured by BIO-RAD LABORATORIES, INC.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Opus - Primary ID 12016687

Device Regulatory Overview

The Opus (Model/Catalog Number: 12016687) is a medical device manufactured by BIO-RAD LABORATORIES, INC.. This product is indexed under FDA Product Code / Category Classification NSU within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
12016687
Product Code / EMDN
NSU
Device Name
CFX Opus Deepwell Dx
Database Sync Date
2026-08-09 09:23:28

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 Opus?

The registered manufacturer of record for Opus is BIO-RAD LABORATORIES, INC..

What is the Primary UDI-DI identifier for Opus?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 12016687.

What classification code is assigned to this device?

This device is registered under product classification code NSU.

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