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Falcon/Pro
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PVC0077Model Falcon – Vascular diagnostic systems
Identity
- Trade Name
- Falcon/Pro EUDAMEDFalcon FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Falcon/Pro EUDAMEDintended for use in the noninvasive evaluation of peripheral vascular pathology in patients FDA UDI
- Model / Reference
- Falcon – Vascular diagnostic systems EUDAMEDPVC0077 EUDAMEDPro FDA UDI
- Description
- intended for use in the noninvasive evaluation of peripheral vascular pathology in patients FDA UDI
Identifiers
- Catalog Number
- PVC0077 FDA UDI
- Primary DI / UDI-DI
- 07290016880007 EUDAMEDFDA UDI
- Basic UDI-DI
- 729001688033CG EUDAMED
- 510(k) Number
- K111416 FDA UDI
- FDA Product Code
- JOP FDA UDI
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2880 FDA UDI
- Market of Registration
- Spain 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
Yes
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
Falcon/Pro by Viasonix Ltd — Class IIa — 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 | 729001688033CG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Viasonix Ltd.
- EUDAMED SRN
- IL-MF-000021015
- Authorised Representative
- Arazy Group GmbH DE-AR-000007685
Sources (2)
- EUDAMED 82a5fd33-ce56-4a54-8d14-827e4696730e 61 fields · synced Jul 14, 2026
- FDA UDI 62adbf8f-f83c-4a5f-afce-13274522547e 35 fields · synced May 30, 2026