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FDR Smart FGXR-EC32S
EUDAMEDClass IIb (EU MDR)
Ref FDR Smart FGXR-EC32SModel GXR-E20S, GXR-E25S, GXR-E32S, GXR-E40S, GXR-EC20S, GXR-EC25S, GXR-EC32S, GXR-EC40S, GXR-EC50S
Identity
- Trade Name
- FDR Smart FGXR-EC32S 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 EUDAMEDFDR Smart FGXR-EC32S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800011121839 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
FDR Smart FGXR-EC32S by DRGEM Corporation — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000111ASGE20004V | Class IIb | Active |
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Manufacturer
- Manufacturer
- DRGEM Corporation
- EUDAMED SRN
- KR-MF-000017990
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED a3f42359-ef5c-4241-916b-289cb9a4bed3 61 fields · synced Jul 9, 2026