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Vascular Navigation PAD, 2.0
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 04056481145613
by Brainlab SE
Identity
- Trade Name
- Vascular Navigation PAD, 2.0 EUDAMEDVascular Navigation PAD FDA UDI
- Generic Name
- Angiographic x-ray system application software FDA UDI
- Device Name
- Vascular Navigation PAD EUDAMED
- Model / Reference
- 04056481145613 EUDAMED2.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481145613 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481VascularPAD4P EUDAMED
- 510(k) Number
- K243432 FDA UDI
- FDA Product Code
- OWB FDA UDILLZ FDA UDI
- EMDN Code
- Z11030192 DIGITAL ANGIOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Angiographic x-ray system application software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 FDA UDI892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
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
Vascular Navigation PAD, 2.0 by Brainlab SE — Class IIb — 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 | 4056481VascularPAD4P | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED 37c82eb0-91a6-4cd7-bcb6-a510dbebe2aa 61 fields · synced May 30, 2026
- FDA UDI db9286e5-5952-470e-86fc-5e8c9af1fa74 33 fields · synced May 30, 2026