Identity
- Trade Name
- Veuron-Brain-pAb EUDAMEDFDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- Veuron-Brain-pAb EUDAMED
- Model / Reference
- V-B-pAb-01 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800086200026 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800086200026 EUDAMED
- 510(k) Number
- K203142 FDA UDI
- FDA Product Code
- LLZ 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
- -1192 EUDAMED
- Market of Registration
- France 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Veuron-Brain-pAb by Heuron Co., Ltd. — Class IIa — FDA_510K, MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203142 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08800086200026 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Heuron Co., Ltd.
- EUDAMED SRN
- KR-MF-000008614
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (3)
- EUDAMED 4c8c2db7-bee7-48a7-a281-f17ec20cd7e6 61 fields · synced Jul 13, 2026
- FDA UDI dcb15ef5-3f16-46ab-84cf-c91f86c0264d 33 fields · synced May 29, 2026
- FDA 510(k) K203142 1 fields · synced May 18, 2026