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405 GSX Precision Resolution Phantom
EUDAMEDClass I (EU MDR)
Ref 405GSXLEModel 405GSXLE
Identity
- Trade Name
- 405 GSX Precision Resolution Phantom EUDAMED
- Device Name
- 405 GSX Precision Resolution Phantom EUDAMED
- Model / Reference
- 405GSXLE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060608881345 EUDAMED
- Basic UDI-DI
- 506060888PH405GSXLEDB EUDAMED
- EMDN Code
- Z11030599 RADIOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
405 GSX Precision Resolution Phantom by Sun Nuclear Corporation — Class I — 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 | 506060888PH405GSXLEDB | Class I | Active |
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Manufacturer
- Manufacturer
- Sun Nuclear Corporation
- EUDAMED SRN
- US-MF-000021541
- Authorised Representative
- Sun Nuclear GmbH DE-AR-000012933
Sources (1)
- EUDAMED 89032097-89bb-4f5d-b233-e3d245aebdad 61 fields · synced Jun 18, 2026