eudamed_udi Primary ID: +EBAN312XGB0-

RK 100 H - Version U.K. (UDI +EBAN312XGB0-)

Manufactured by BANDELIN electronic GmbH & Co. KG

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

Scannable UDI-DI Representation

Device Regulatory Overview

The RK 100 H - Version U.K. (Model/Catalog Number: 312-GB) is a medical device manufactured by BANDELIN electronic GmbH & Co. KG. This product is indexed under FDA Product Code / Category Classification Z12011302 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 312-GB
Product Code / EMDN: Z12011302
Device Name: SONOREX High-performance ultrasonic baths
Database Sync Date: 2026-08-09 16:48:49

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 RK 100 H - Version U.K.?

The registered manufacturer of record for RK 100 H - Version U.K. is BANDELIN electronic GmbH & Co. KG.

What is the Primary UDI-DI identifier for RK 100 H - Version U.K.?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is +EBAN312XGB0-.

What classification code is assigned to this device?

This device is registered under product classification code Z12011302.

Similar Classification Devices (Z12011302)

Other Devices by BANDELIN electronic GmbH & Co. KG

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