GUDIDData
gudid Primary ID: Sonix BC-EA8000-9000

Baichen (UDI Sonix BC-EA8000-9000)

Manufactured by NINGBO BAICHEN MEDICAL DEVICES CO., LTD

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Baichen - Primary ID Sonix BC-EA8000-9000

Device Regulatory Overview

The Baichen (Model/Catalog Number: Sonix BC-EA8000-9000) is a medical device manufactured by NINGBO BAICHEN MEDICAL DEVICES CO., LTD. This product is indexed under FDA Product Code / Category Classification ITI within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
Sonix BC-EA8000-9000
Product Code / EMDN
ITI
Device Name
Database Sync Date
2026-08-09 09:06:36

Full Regulatory Attributes

🔒 Token Gated
{
    "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 Baichen?

The registered manufacturer of record for Baichen is NINGBO BAICHEN MEDICAL DEVICES CO., LTD.

What is the Primary UDI-DI identifier for Baichen?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Sonix BC-EA8000-9000.

What classification code is assigned to this device?

This device is registered under product classification code ITI.

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