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Virtua XR
EUDAMEDFDA UDIClass I (EU MDR)
Ref VirtuaXRModel Virtua Medical Disc Publisher
Identity
- Trade Name
- Virtua XR EUDAMEDCodonics Virtua® XR Medical Disc Publisher FDA UDI
- Generic Name
- DICOM image data disc-recording unit FDA UDI
- Device Name
- Virtua EUDAMEDIntegrated Virtua XR DICOM Server & Medical Disc (CD/DVD) Publisher System FDA UDI
- Model / Reference
- Virtua Medical Disc Publisher EUDAMEDVirtuaXR EUDAMEDVirtua XR FDA UDI
- Description
- Integrated Virtua XR DICOM Server & Medical Disc (CD/DVD) Publisher System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814905020335 EUDAMEDFDA UDI
- Basic UDI-DI
- 081490502VRMDP01KK EUDAMED
- Direct Marketing DI
- 00814905020335 EUDAMED
- FDA Product Code
- LMD FDA UDI
- EMDN Code
- Z11069099 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- DICOM image data disc-recording unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.2020 FDA UDI
- Market of Registration
- Netherlands 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
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Virtua XR by Codonics Inc. — Class I — 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 | 081490502VRMDP01KK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Codonics Inc.
- EUDAMED SRN
- US-MF-000008190
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 3ac5c9ce-d04f-4f4a-bb02-b0267cb8c1dc 61 fields · synced Jun 8, 2026
- FDA UDI 1d5219b7-6939-4c87-8858-16d8389edf22 34 fields · synced May 29, 2026