gudid
Primary ID: BC01-AU
Babi.Plus (UDI BC01-AU)
Manufactured by GALEMED CORPORATION
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Babi.Plus - Primary ID BC01-AU
Device Regulatory Overview
The Babi.Plus (Model/Catalog Number: BC01-AU) is a medical device manufactured by GALEMED CORPORATION. This product is indexed under FDA Product Code / Category Classification BYE within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- BC01-AU
- Product Code / EMDN
- BYE
- Device Name
- 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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Get API Token Access ($49/mo)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 BC01-AU.
What classification code is assigned to this device?
This device is registered under product classification code BYE.
Similar Classification Devices (BYE)
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