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FDR Smart FGXR-Z52S
EUDAMEDClass IIb (EU MDR)
Ref FDR Smart FGXR-Z52SModel DIAMOND-5B, DIAMOND-6B, DIAMOND-8B
Identity
- Trade Name
- FDR Smart FGXR-Z52S EUDAMED
- Device Name
- Diagnostic X-ray System EUDAMED
- Model / Reference
- DIAMOND-5B, DIAMOND-6B, DIAMOND-8B EUDAMEDFDR Smart FGXR-Z52S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800011122102 EUDAMED
- Basic UDI-DI
- 88000111ASDIA2000E2 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-Z52S by DRGEM Corporation — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Stationary basic diagnostic x-ray system, analogue.
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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 | 88000111ASDIA2000E2 | 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 a4c0e92b-8f6a-49f1-8706-524fdb8acbad 61 fields · synced Jun 18, 2026