SURESIGN Digital Ovulation Rapid Test (UDI 01007-9)
Manufactured by Guangzhou Decheng Biotechnology Co., LTD
Device Regulatory Overview
The SURESIGN Digital Ovulation Rapid Test (Model/Catalog Number: 01007-9) is a medical device manufactured by Guangzhou Decheng Biotechnology Co., LTD. This product is indexed under FDA Product Code / Category Classification NGE within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 01007-9
- Product Code / EMDN
- NGE
- Device Name
- 1ct Digital Ovulation Rapid Test Holder + 20ct Digital Ovulation Rapid Test Stick
- 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 Digital Ovulation Rapid Test?
The registered manufacturer of record for SURESIGN Digital Ovulation Rapid Test is Guangzhou Decheng Biotechnology Co., LTD.
What is the Primary UDI-DI identifier for SURESIGN Digital Ovulation Rapid Test?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 01007-9.
What classification code is assigned to this device?
This device is registered under product classification code NGE.
Similar Classification Devices (NGE)
Other Devices by Guangzhou Decheng Biotechnology Co., LTD
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