gudid
Primary ID: FDR Clinica FGXR-40S
FDR Clinica (UDI FDR Clinica FGXR-40S)
Manufactured by DRGEM Corporation
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for FDR Clinica - Primary ID FDR Clinica FGXR-40S
Device Regulatory Overview
The FDR Clinica (Model/Catalog Number: FDR Clinica FGXR-40S) 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 Clinica FGXR-40S
- Product Code / EMDN
- KPR
- Device Name
- 220-230V~ / 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 FDR Clinica?
The registered manufacturer of record for FDR Clinica is DRGEM Corporation.
What is the Primary UDI-DI identifier for FDR Clinica?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is FDR Clinica FGXR-40S.
What classification code is assigned to this device?
This device is registered under product classification code KPR.
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