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Rayvolve
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref Rayvolve - VM/Cloud (Version 5)Ref Rayvolve- On premise (Version 2)510(k) K260378Ref Rayvolve - VM/ Cloud (Version 6)Ref Rayvolve V7.0.0 Full CloudRef Rayvolve - On-premise (Version 5)Ref Rayvolve - Full cloud (Version 6)
by AZmed
Identity
- Trade Name
- Rayvolve EUDAMED
- Device Name
- Rayvolve EUDAMED
- Model / Reference
- Rayvolve - VM/Cloud (Version 5) EUDAMEDRayvolve- On premise (Version 2) EUDAMEDRayvolve - VM/ Cloud (Version 6) EUDAMEDRayvolve V7.0.0 Full Cloud EUDAMEDRayvolve - On-premise (Version 5) EUDAMEDRayvolve - Full cloud (Version 6) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 37700180710914 EUDAMED37700180710082 EUDAMED37700180711454 EUDAMED37700180711904 EUDAMED37700180711140 EUDAMED37700180711386 EUDAMED
- Basic UDI-DI
- 3770018071008VP EUDAMED
- Direct Marketing DI
- 37700180710914 EUDAMED37700180710082 EUDAMED37700180711454 EUDAMED37700180711904 EUDAMED37700180711140 EUDAMED37700180711386 EUDAMED
- EMDN Code
- Z11060292 DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS - MEDICAL DEVICE SOFTWARE EUDAMEDZ11060282 DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- France 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Rayvolve by AZmed — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K260378 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 3770018071008VP | Class IIa | Active |
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Manufacturer
- Manufacturer
- AZmed
- EUDAMED SRN
- FR-MF-000014277
Sources (7)
- EUDAMED 3e1d94af-35ea-4928-a2af-b180b4417029 61 fields · synced Jul 30, 2026
- EUDAMED 597c6951-6dec-4c47-867d-c987429f1b86 85 fields · synced May 17, 2026
- EUDAMED 13a8dfaa-fa3a-42bb-b6a2-2bf32c4910b3 61 fields · synced May 17, 2026
- EUDAMED 1571f941-3186-4f10-aeda-0e0b95495b5e 61 fields · synced Jun 20, 2026
- EUDAMED f4b6b667-6d72-4078-9315-bbd6f519c378 61 fields · synced Jul 9, 2026
- EUDAMED 3348f336-b82c-4b15-8474-5db47e3d13b6 61 fields · synced Jul 30, 2026
- FDA 510(k) K260378 1 fields · synced May 29, 2026