eudamed_udi
Primary ID: 06955792734395
Unspecified Brand (UDI 06955792734395)
Manufactured by Sansure Biotech Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Unspecified Brand - Primary ID 06955792734395
Device Regulatory Overview
The Unspecified Brand (Model/Catalog Number: S3230E-48) is a medical device manufactured by Sansure Biotech Inc.. This product is indexed under FDA Product Code / Category Classification W0105050201 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- S3230E-48
- Product Code / EMDN
- W0105050201
- Device Name
- Entamoeba Histolytica Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
- Database Sync Date
- 2026-08-09 18:33:30
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 Unspecified Brand?
The registered manufacturer of record for Unspecified Brand is Sansure Biotech Inc..
What is the Primary UDI-DI identifier for Unspecified Brand?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06955792734395.
What classification code is assigned to this device?
This device is registered under product classification code W0105050201.
Similar Classification Devices (W0105050201)
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