Babi.Plus (UDI BC23-HD)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Babi.Plus (Model/Catalog Number: BC23-HD) is a medical device manufactured by GALEMED CORPORATION. This product is indexed under FDA Product Code / Category Classification BZD within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: BC23-HD
Product Code / EMDN: BZD
Device Name: Distributed by Teleflex
Database Sync Date: 2026-08-09 09:15:32

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 Babi.Plus?

The registered manufacturer of record for Babi.Plus is GALEMED CORPORATION.

What is the Primary UDI-DI identifier for Babi.Plus?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is BC23-HD.

What classification code is assigned to this device?

This device is registered under product classification code BZD.

Similar Classification Devices (BZD)

Other Devices by GALEMED CORPORATION

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