gudid Primary ID: ROSE/WHITE

DELTAone (UDI ROSE/WHITE)

Manufactured by Heine Optotechnik GmbH & Co. KG

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

Scannable UDI-DI Representation

Device Regulatory Overview

The DELTAone (Model/Catalog Number: ROSE/WHITE) is a medical device manufactured by Heine Optotechnik GmbH & Co. KG. This product is indexed under FDA Product Code / Category Classification KYT within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: ROSE/WHITE
Product Code / EMDN: KYT
Device Name
Database Sync Date: 2026-08-09 09:26:12

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 DELTAone?

The registered manufacturer of record for DELTAone is Heine Optotechnik GmbH & Co. KG.

What is the Primary UDI-DI identifier for DELTAone?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is ROSE/WHITE.

What classification code is assigned to this device?

This device is registered under product classification code KYT.

Similar Classification Devices (KYT)

Other Devices by Heine Optotechnik GmbH & Co. KG

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