CK-MB Rapid Test (UDI D-CCK4006L)
Manufactured by Hangzhou Clongene Biotech Co., Ltd.
Device Regulatory Overview
The CK-MB Rapid Test (Model/Catalog Number: CCK4001, CCK4002) is a medical device manufactured by Hangzhou Clongene Biotech Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0102160701 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- CCK4001, CCK4002
- Product Code / EMDN
- W0102160701
- Device Name
- CK-MB Rapid Test
- Database Sync Date
- 2026-08-09 18:06:58
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 CK-MB Rapid Test?
The registered manufacturer of record for CK-MB Rapid Test is Hangzhou Clongene Biotech Co., Ltd..
What is the Primary UDI-DI identifier for CK-MB Rapid Test?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-CCK4006L.
What classification code is assigned to this device?
This device is registered under product classification code W0102160701.
Similar Classification Devices (W0102160701)
Other Devices by Hangzhou Clongene Biotech Co., Ltd.
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