Sun Nuclear Advanced Electron Density Phantom
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Advanced Electron Density Phantom EUDAMEDSun Nuclear Advanced Electron Density Phantom FDA UDI
- Generic Name
- CT phantom, test object FDA UDI
- Device Name
- Advanced Electron Density Phantom EUDAMED
- Model / Reference
- 1467 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060608881253 EUDAMEDB13614670 FDA UDI
- Basic UDI-DI
- 5060608881467PHKV EUDAMED
- FDA Product Code
- LHO FDA UDI
- EMDN Code
- Z11030599 RADIOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- CT phantom, test object FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1940 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: CT phantom, test object
Sun Nuclear Advanced Electron Density Phantom by Sun Nuclear Corporation — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Manufacturer's product page: Advanced Electron Density Phantom Tissue-Equivalent CT-to-Electron Density Calibration
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sun Nuclear Corporation
Sources (2)
- FDA UDI 013bffd5-4ba8-49c4-8c6e-4a5ffad01024 32 fields · synced Jul 31, 2026
- EUDAMED 92d790ad-01fb-410e-8789-3a45bae60e75 61 fields · synced Jul 31, 2026