← Back to catalogue
Dolphin/4D
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PVC0201Model Dolphin product family – Transcranial Doppler systems
Identity
- Trade Name
- Dolphin/4D EUDAMEDDolphin FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Dolphin/IQ EUDAMEDThe Dolphin/4D is a medical Doppler device intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric. The Dolphin/4D system can be used in hospitals, clinics and physician offices FDA UDI
- Model / Reference
- Dolphin product family – Transcranial Doppler systems EUDAMEDPVC0201 EUDAMED4D FDA UDI
- Description
- The Dolphin/4D is a medical Doppler device intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric. The Dolphin/4D system can be used in hospitals, clinics and physician offices FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016880311 EUDAMEDFDA UDI
- Basic UDI-DI
- 729001688034CJ EUDAMED
- 510(k) Number
- K191023 FDA UDI
- FDA Product Code
- ITX FDA UDIIYN 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
- 892.1570 FDA UDI892.1550 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dolphin/4D 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 | 729001688034CJ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Viasonix Ltd.
- EUDAMED SRN
- IL-MF-000021015
- Authorised Representative
- Arazy Group GmbH DE-AR-000007685
Sources (2)
- EUDAMED ca747896-656d-401a-a87d-00a8d6294730 61 fields · synced Jul 23, 2026
- FDA UDI e1cc43a7-e410-4d31-ad42-73cafc472dd8 35 fields · synced May 30, 2026