gudid
Primary ID: FDR Smart FGXR-U40S
DRGEM (UDI FDR Smart FGXR-U40S)
Manufactured by DRGEM Corporation
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for DRGEM - Primary ID FDR Smart FGXR-U40S
Device Regulatory Overview
The DRGEM (Model/Catalog Number: FDR Smart FGXR-U40S) is a medical device manufactured by DRGEM Corporation. This product is indexed under FDA Product Code / Category Classification KPR within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- FDR Smart FGXR-U40S
- Product Code / EMDN
- KPR
- Device Name
- 100-240V/125kV
- Database Sync Date
- 2026-08-09 09:26:40
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 DRGEM?
The registered manufacturer of record for DRGEM is DRGEM Corporation.
What is the Primary UDI-DI identifier for DRGEM?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is FDR Smart FGXR-U40S.
What classification code is assigned to this device?
This device is registered under product classification code KPR.
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