B WELL (UDI ePA-09B4)
Manufactured by Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.
Device Regulatory Overview
The B WELL (Model/Catalog Number: ePA-09B4) is a medical device manufactured by Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.. This product is indexed under FDA Product Code / Category Classification DXN within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- ePA-09B4
- Product Code / EMDN
- DXN
- Device Name
- Blood pressure monitor
- Database Sync Date
- 2026-08-09 09:05:28
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 B WELL?
The registered manufacturer of record for B WELL is Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd..
What is the Primary UDI-DI identifier for B WELL?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is ePA-09B4.
What classification code is assigned to this device?
This device is registered under product classification code DXN.
Similar Classification Devices (DXN)
Other Devices by Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.
Programmatic Export
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JSON API Endpoint