Identity
- Trade Name
- Nexus DR EUDAMEDVarex Imaging Nexus DR Digital Imaging System FDA UDI
- Generic Name
- X-ray system computer, diagnostic, general-purpose FDA UDI
- Device Name
- Varex Nexus DR Digital X-ray Imaging System EUDAMED
- Model / Reference
- v4.18 EUDAMEDv4.0.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854344007771 EUDAMED00854344007290 FDA UDI
- Basic UDI-DI
- 08543440070187 EUDAMED
- Direct Marketing DI
- 00854344007771 EUDAMED
- FDA Product Code
- MQB FDA UDI
- EMDN Code
- Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE 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 UDI
- Special Device Type
- Software 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Nexus DR 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 | 08543440070187 | 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 6ba6a631-b664-455a-a246-af76c7564d4a 61 fields · synced Jul 20, 2026
- FDA UDI 42cb226b-f9ed-41b8-81d5-a1d50923d655 32 fields · synced May 30, 2026