Opiates Rapid Test (UDI D-DOPI100Y2)
Manufactured by Hangzhou Clongene Biotech Co., Ltd.
Device Regulatory Overview
The Opiates Rapid Test (Model/Catalog Number: DOPI1001, DOPI1002) is a medical device manufactured by Hangzhou Clongene Biotech Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0102160508 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- DOPI1001, DOPI1002
- Product Code / EMDN
- W0102160508
- Device Name
- Opiates Rapid Test
- Database Sync Date
- 2026-08-09 16:50:52
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 Opiates Rapid Test?
The registered manufacturer of record for Opiates Rapid Test is Hangzhou Clongene Biotech Co., Ltd..
What is the Primary UDI-DI identifier for Opiates Rapid Test?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-DOPI100Y2.
What classification code is assigned to this device?
This device is registered under product classification code W0102160508.
Similar Classification Devices (W0102160508)
Other Devices by Hangzhou Clongene Biotech Co., Ltd.
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