SURESIGN Pregnancy Rapid Test (UDI 01000-0)
Manufactured by Guangzhou Decheng Biotechnology Co., LTD
Device Regulatory Overview
The SURESIGN Pregnancy Rapid Test (Model/Catalog Number: 01000-0) is a medical device manufactured by Guangzhou Decheng Biotechnology Co., LTD. This product is indexed under FDA Product Code / Category Classification LCX within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 01000-0
- Product Code / EMDN
- LCX
- Device Name
- 5ct 25mIU - Single Step Pregnancy Test
- Database Sync Date
- 2026-08-09 09:08:50
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 SURESIGN Pregnancy Rapid Test?
The registered manufacturer of record for SURESIGN Pregnancy Rapid Test is Guangzhou Decheng Biotechnology Co., LTD.
What is the Primary UDI-DI identifier for SURESIGN Pregnancy Rapid Test?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 01000-0.
What classification code is assigned to this device?
This device is registered under product classification code LCX.
Similar Classification Devices (LCX)
Other Devices by Guangzhou Decheng Biotechnology Co., LTD
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