Identity
- Trade Name
- EDGE Detector (BNC) EUDAMEDFDA UDI
- Generic Name
- Solid-state-semiconductor radiation measuring probe FDA UDI
- Device Name
- Edge Detector EUDAMEDRadiation therapy QA device. FDA UDI
- Model / Reference
- 1118 EUDAMED11180000Z FDA UDI
- Description
- Radiation therapy QA device. FDA UDI
Identifiers
- Catalog Number
- 11180000Z FDA UDI
- Primary DI / UDI-DI
- 05060608880072 EUDAMEDFDA UDI
- Basic UDI-DI
- 506060888DPEdgeDTD 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
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
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Solid-state-semiconductor radiation measuring probe
EDGE Detector (BNC) by Sun Nuclear Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Solid-state-semiconductor radiation measuring probe.
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Cleared under the same submission
K051921 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sun Nuclear Corp.
Sources (2)
- FDA UDI f0ff42a9-689a-4991-bec9-d99e6986f98f 36 fields · synced Jul 23, 2026
- EUDAMED 6aa6252f-8b40-4dc9-9930-a552fa2e34d8 61 fields · synced Jul 23, 2026