Baichen (UDI Sonix BC-EA8000-530)
Manufactured by NINGBO BAICHEN MEDICAL DEVICES CO., LTD
Device Regulatory Overview
The Baichen (Model/Catalog Number: Sonix BC-EA8000-530) 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-EA8000-530
- Product Code / EMDN
- ITI
- Device Name
- Database Sync Date
- 2026-08-09 09:06:36
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 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-EA8000-530.
What classification code is assigned to this device?
This device is registered under product classification code ITI.
Similar Classification Devices (ITI)
Other Devices by NINGBO BAICHEN MEDICAL DEVICES CO., LTD
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