Identity
- Trade Name
- Nexus DRF EUDAMEDVarex Digital Imaging System, Nexus, RF/DR, Digital Receptor FDA UDI
- Generic Name
- X-ray system computer, diagnostic, general-purpose FDA UDI
- Device Name
- Varex Nexus DRF Digital X-ray Imaging System EUDAMED
- Model / Reference
- i5 EUDAMEDNexus-DRF FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854344007054 EUDAMEDFDA UDI
- Basic UDI-DI
- 08543440070289 EUDAMED
- Direct Marketing DI
- 00854344007054 EUDAMED
- 510(k) Number
- K130318 FDA UDI
- FDA Product Code
- MQB FDA UDIJAA FDA UDI
- EMDN Code
- Z11030599 RADIOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- X-ray system computer, diagnostic, general-purpose FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI892.1650 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
Yes
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
Nexus DRF by Varex Imaging Corporation — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 08543440070289 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Varex Imaging Corporation
- EUDAMED SRN
- US-MF-000028124
- Authorised Representative
- Arazy Group GmbH DE-AR-000007685
Sources (2)
- EUDAMED 7446612b-a24b-40b5-a5e4-802709cfb46b 61 fields · synced Jun 9, 2026
- FDA UDI 022c1688-179a-4d8e-8ad8-d0d3672bc254 33 fields · synced May 30, 2026