Identity
- Trade Name
- Varex Imaging FDA UDI
- Generic Name
- X-ray system tube FDA UDI
- Device Name
- X-Ray Tube Assembly - RAD EUDAMEDDiagnostic X-Ray RAD Tube FDA UDI
- Model / Reference
- X-Ray Tube Assembly - RAD EUDAMEDDiagnostic X-Ray Tube VRX-RAD FDA UDI
- Description
- Diagnostic X-Ray RAD Tube FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854344007559 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00854344007559 EUDAMED
- FDA Product Code
- ITY FDA UDI
- EMDN Code
- Z11039012 X-RAY TUBE ASSEMBLY EUDAMED
- GMDN Term
- X-ray system tube FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1760 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: X-ray system tube
Varex Imaging by Varex Imaging Corporation — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as X-ray system tube.
- Medical CT X-Ray Tube — Wuxi Guochen Medical Technology Co., Ltd. · Class I
- SMARTBEAM — Beijing Smartbeam Technology Co., LTD · Class I
- Medical CT X-Ray Tube Assembly — Wuxi Guochen Medical Technology Co., Ltd. · Class I
- Richardson Electronics — RICHARDSON ELECTRONICS · Class I
- Medical diagnostic rotating anode X-ray tube — Beijing Smartbeam Medical Devices Co., LTD · Class I
- SMARTBEAM — Beijing Smartbeam Technology Co., LTD · Class I
- Medical CT X-Ray Tube Assembly — Wuxi Guochen Medical Technology Co., Ltd. · Class I
- Amirix Imaging — AMIRIX IMAGING · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Varex Imaging Corporation
Sources (2)
- FDA UDI cb4bd1fc-cb92-4dac-b684-97100d4d9afb 33 fields · synced Jun 19, 2026
- EUDAMED 484a5300-76b1-4d6b-9295-ddc4f7304cc2 61 fields · synced Jun 19, 2026