GUDIDData
gudid Primary ID: ROTIXA 500, Standard, N2

ROTIXA 500 RS (UDI ROTIXA 500, Standard, N2)

Manufactured by Andreas Hettich GmbH

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ROTIXA 500 RS - Primary ID ROTIXA 500, Standard, N2

Device Regulatory Overview

The ROTIXA 500 RS (Model/Catalog Number: ROTIXA 500, Standard, N2) is a medical device manufactured by Andreas Hettich GmbH. This product is indexed under FDA Product Code / Category Classification QBV within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
ROTIXA 500, Standard, N2
Product Code / EMDN
QBV
Device Name
Floor standing centrifuge for preparation of cell concentrate and/or plasma concentrate
Database Sync Date
2026-08-09 09:26:15

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of ROTIXA 500 RS?

The registered manufacturer of record for ROTIXA 500 RS is Andreas Hettich GmbH.

What is the Primary UDI-DI identifier for ROTIXA 500 RS?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is ROTIXA 500, Standard, N2.

What classification code is assigned to this device?

This device is registered under product classification code QBV.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint