Fully Automatic ELISA Analyzer (UDI 06974312710152)
Manufactured by Changsha Imadek Intelligent Technology Co., Ltd.
Device Regulatory Overview
The Fully Automatic ELISA Analyzer (Model/Catalog Number: ME-8400Pro) is a medical device manufactured by Changsha Imadek Intelligent Technology Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W02010299 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- ME-8400Pro
- Product Code / EMDN
- W02010299
- Device Name
- Fully Automatic ELISA Analyzer
- Database Sync Date
- 2026-08-09 17:35:51
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 Fully Automatic ELISA Analyzer?
The registered manufacturer of record for Fully Automatic ELISA Analyzer is Changsha Imadek Intelligent Technology Co., Ltd..
What is the Primary UDI-DI identifier for Fully Automatic ELISA Analyzer?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06974312710152.
What classification code is assigned to this device?
This device is registered under product classification code W02010299.
Similar Classification Devices (W02010299)
Other Devices by Changsha Imadek Intelligent Technology Co., Ltd.
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