Identity
- Trade Name
- SunSILICON EUDAMEDFDA UDI
- Generic Name
- Solid-state-semiconductor radiation measuring probe FDA UDI
- Device Name
- SunSILICON EUDAMEDThe SunSILICON detector is intended for use as a relative dosimetry detector in measurements of ionizing radiation emitted from a treatment delivery device. FDA UDI
- Model / Reference
- 1048 EUDAMEDFDA UDI
- Description
- The SunSILICON detector is intended for use as a relative dosimetry detector in measurements of ionizing radiation emitted from a treatment delivery device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060608881192 EUDAMEDFDA UDI
- Basic UDI-DI
- 506060888DP1048WT EUDAMED
- 510(k) Number
- K051921 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11010180 LINEAR ACCELERATORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Solid-state-semiconductor radiation measuring probe FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Accelerator system quality assurance device
SunSILICON by Sun Nuclear Corporation — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506060888DP1048WT | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Sun Nuclear Corporation
- EUDAMED SRN
- US-MF-000020245
- Authorised Representative
- Sun Nuclear GmbH DE-AR-000012933
Sources (2)
- EUDAMED 320e36e7-5455-4947-a044-287e54eb9b20 61 fields · synced Jul 27, 2026
- FDA UDI 75e77c91-96d8-4d5f-94be-c35fe8895c0e 35 fields · synced May 30, 2026