gudid
Primary ID: DPO-396FPA
Amazewell (UDI DPO-396FPA)
Manufactured by Guangzhou Decheng Biotechnology Co., LTD
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Amazewell - Primary ID DPO-396FPA
Device Regulatory Overview
The Amazewell (Model/Catalog Number: DPO-396FPA) is a medical device manufactured by Guangzhou Decheng Biotechnology Co., LTD. This product is indexed under FDA Product Code / Category Classification PUX within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- DPO-396FPA
- Product Code / EMDN
- PUX
- Device Name
- Amazewell D-Pen Oral Fluid Drug Test, 9-Panel, 25T/Box
- Database Sync Date
- 2026-08-09 09:37:39
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 Amazewell?
The registered manufacturer of record for Amazewell is Guangzhou Decheng Biotechnology Co., LTD.
What is the Primary UDI-DI identifier for Amazewell?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is DPO-396FPA.
What classification code is assigned to this device?
This device is registered under product classification code PUX.
Similar Classification Devices (PUX)
Other Devices by Guangzhou Decheng Biotechnology Co., LTD
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