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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
- 08800011122119 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
FDR Smart FGXR-Z52S 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 | 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 8ce55c2c-1519-428c-b26b-730c3c3d634c 61 fields · synced Aug 3, 2026