Identity
- Trade Name
- Nexus DR EUDAMED
- Device Name
- Varex Nexus DR Digital X-ray Imaging System EUDAMED
- Model / Reference
- v4.19 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00854344007795 EUDAMED
- Basic UDI-DI
- 08543440070187 EUDAMED
- Direct Marketing DI
- 00854344007795 EUDAMED
- EMDN Code
- Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Nexus DR by Varex Imaging Corporation — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08543440070187 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Varex Imaging Corporation
- EUDAMED SRN
- US-MF-000028124
- Authorised Representative
- Arazy Group GmbH DE-AR-000007685
Sources (1)
- EUDAMED 8e76fc43-4dc4-4c54-9784-0d93ee23018e 61 fields · synced Jun 9, 2026