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Snapshot 2026-10-11 · Link to EUDAMED

FDR Smart FGXR-U40S

UDI-DI 08800011120818Basic UDI-DI 88000111ASGS20009P

Class IIb · MDR · DRGEM Corporation

Identification
Model
GXR-32S, GXR-40S, GXR-52S, GXR-68S, GXR-82S, GXR-C32S, GXR-C40S, GXR-C52S, GXR-U32S, GXR-U40S
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

No certificate found.

Snapshot 2026-10-11 · Link to EUDAMED

Manufacturer

DRGEM Corporation

SRN KR-MF-000017990

KR · Gwangmyeong

manufacturer

Authorised representative: Obelis s.a. (BE-AR-000000106)

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Canonical device page: /device/fdr-smart-fgxr-u40s-0818 · UDI page: /udi/08800011120818

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