gudid
Primary ID: BK400
BIOBASE (UDI BK400)
Manufactured by Biobase Biodustry(Shandong)Co., Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for BIOBASE - Primary ID BK400
Device Regulatory Overview
The BIOBASE (Model/Catalog Number: BK400) is a medical device manufactured by Biobase Biodustry(Shandong)Co., Ltd.. This product is indexed under FDA Product Code / Category Classification JJE within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- BK400
- Product Code / EMDN
- JJE
- Device Name
- BK400 and BK-400 are identical device models; the difference is only the use of a hyphen
- Database Sync Date
- 2026-08-09 09:06:42
Full Regulatory Attributes
🔒 Token Gated
{
"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 BIOBASE?
The registered manufacturer of record for BIOBASE is Biobase Biodustry(Shandong)Co., Ltd..
What is the Primary UDI-DI identifier for BIOBASE?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is BK400.
What classification code is assigned to this device?
This device is registered under product classification code JJE.
Similar Classification Devices (JJE)
Other Devices by Biobase Biodustry(Shandong)Co., Ltd.
Programmatic Export
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