gudid
Primary ID: U643
URiSCAN 2 ACR strip (UDI U643)
Manufactured by YD Diagnostics CORP.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for URiSCAN 2 ACR strip - Primary ID U643
Device Regulatory Overview
The URiSCAN 2 ACR strip (Model/Catalog Number: U643) is a medical device manufactured by YD Diagnostics CORP.. This product is indexed under FDA Product Code / Category Classification JIR within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- U643
- Product Code / EMDN
- JIR
- Device Name
- Urinalysis dip and read strips for URiSCAN urine analyzer.Test for Microalbumin and Creatinine in urine.
- Database Sync Date
- 2026-08-09 09:27:59
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 URiSCAN 2 ACR strip?
The registered manufacturer of record for URiSCAN 2 ACR strip is YD Diagnostics CORP..
What is the Primary UDI-DI identifier for URiSCAN 2 ACR strip?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is U643.
What classification code is assigned to this device?
This device is registered under product classification code JIR.
Similar Classification Devices (JIR)
Other Devices by YD Diagnostics CORP.
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