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FDR Smart FGXR-E20S

EUDAMED

Class IIb (EU MDR)

Ref FDR Smart FGXR-E20SModel GXR-E20S, GXR-E25S, GXR-E32S, GXR-E40S, GXR-EC20S, GXR-EC25S, GXR-EC32S, GXR-EC40S, GXR-EC50S

by DRGEM Corporation

Identity

Trade Name
FDR Smart FGXR-E20S EUDAMED
Device Name
Diagnostic X-ray System EUDAMED
Model / Reference
GXR-E20S, GXR-E25S, GXR-E32S, GXR-E40S, GXR-EC20S, GXR-EC25S, GXR-EC32S, GXR-EC40S, GXR-EC50S EUDAMED
FDR Smart FGXR-E20S EUDAMED

Identifiers

Primary DI / UDI-DI
08800011121686 EUDAMED
Basic UDI-DI
88000111ASGE20004V EUDAMED
EMDN Code
Z110310 MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Netherlands EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

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

Category: Stationary basic diagnostic x-ray system, analogue

FDR Smart FGXR-E20S by DRGEM Corporation — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
DRGEM Corporation
EUDAMED SRN
KR-MF-000017990
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (1)

  • EUDAMED 1d92a746-2e5f-43c5-9be5-62d117717b6c 61 fields · synced Jul 30, 2026