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GXR-ES, ECS Diagnostic X-ray System

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref GXR-EC25SModel GXR-E20S, GXR-E25S, GXR-E32S, GXR-E40S, GXR-EC20S, GXR-EC25S, GXR-EC32S, GXR-EC40S, GXR-EC50S

by DRGEM Corporation

Identity

Trade Name
GXR-EC25S EUDAMED
GXR-ES,ECS Diagnostic X-ray System FDA UDI
Generic Name
Stationary basic diagnostic x-ray system, analogue FDA UDI
Device Name
Diagnostic X-ray System EUDAMED
The DRGME’s 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) : 100-120 V~ / 125kV FDA UDI
Model / Reference
GXR-EC25S EUDAMEDFDA UDI
GXR-E20S, GXR-E25S, GXR-E32S, GXR-E40S, GXR-EC20S, GXR-EC25S, GXR-EC32S, GXR-EC40S, GXR-EC50S EUDAMED
Description
The DRGME’s 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) : 100-120 V~ / 125kV FDA UDI

Identifiers

Primary DI / UDI-DI
08800011121884 EUDAMEDFDA UDI
Basic UDI-DI
88000111ASGE20004V EUDAMED
510(k) Number
K232178 FDA UDI
FDA Product Code
KPR FDA UDI
EMDN Code
Z110310 MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY EUDAMED
GMDN Term
Stationary basic diagnostic x-ray system, analogue FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
892.1680 FDA UDI
Market of Registration
Poland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Stationary basic diagnostic x-ray system, analogue

GXR-ES, ECS Diagnostic X-ray System by DRGEM Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Stationary basic diagnostic x-ray system, analogue.

Cleared under the same submission

K232178 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DRGEM Corporation

Sources (2)

  • FDA UDI 6307befe-eaad-41a3-8fba-354cccf47a89 34 fields · synced Jun 18, 2026
  • EUDAMED 6981d6ec-9fe5-4f0a-8a1e-dd1a04939fb6 61 fields · synced Jun 18, 2026