gudid
Primary ID: GXR-EC32S
GXR-ES,ECS Diagnostic X-ray System (UDI GXR-EC32S)
Manufactured by DRGEM Corporation
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for GXR-ES,ECS Diagnostic X-ray System - Primary ID GXR-EC32S
Device Regulatory Overview
The GXR-ES,ECS Diagnostic X-ray System (Model/Catalog Number: GXR-EC32S) 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
- GXR-EC32S
- Product Code / EMDN
- KPR
- Device Name
- The DRGMEs directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device Identifier) is assigned based on the system model name, power specifications, and maximum x-ray tube voltage of the x-ray tube. *Power Specification (V) / maximum tube Voltage (kV) : 200-240 V~ / 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 GXR-ES,ECS Diagnostic X-ray System?
The registered manufacturer of record for GXR-ES,ECS Diagnostic X-ray System is DRGEM Corporation.
What is the Primary UDI-DI identifier for GXR-ES,ECS Diagnostic X-ray System?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is GXR-EC32S.
What classification code is assigned to this device?
This device is registered under product classification code KPR.
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