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VUNO Med-DeepBrain
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref VN-M-06
by VUNO Inc.
Identity
- Trade Name
- VUNO Med-DeepBrain FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- VUNO Med-DeepBrain EUDAMED
- Model / Reference
- VN-M-06 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800045800106 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000458VDPYT EUDAMED
- Direct Marketing DI
- 08800045800106 EUDAMED
- 510(k) Number
- K231398 FDA UDI
- FDA Product Code
- LLZ FDA UDIQIH FDA UDI
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
VUNO Med-DeepBrain by VUNO Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, 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 | K231398 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 88000458VDPYT | Class IIa | Active |
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Manufacturer
- Manufacturer
- VUNO Inc.
- EUDAMED SRN
- KR-MF-000022266
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 0e9272c1-065b-473c-9996-f75da25330ed 61 fields · synced Aug 4, 2026
- FDA UDI 538ce31f-c19d-41a9-bbe2-054c83bd0d4b 33 fields · synced May 29, 2026
- FDA 510(k) K231398 1 fields · synced May 18, 2026