gudid
Primary ID: 4D
Dolphin (UDI 4D)
Manufactured by VIASONIX LTD
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Dolphin - Primary ID 4D
Device Regulatory Overview
The Dolphin (Model/Catalog Number: 4D) is a medical device manufactured by VIASONIX LTD. This product is indexed under FDA Product Code / Category Classification ITX within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 4D
- Product Code / EMDN
- ITX
- Device Name
- The Dolphin/4D is a medical Doppler device intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric. TheDolphin/4D system can be used in hospitals, clinics and physician offices
- Database Sync Date
- 2026-08-09 09:18:18
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Dolphin?
The registered manufacturer of record for Dolphin is VIASONIX LTD.
What is the Primary UDI-DI identifier for Dolphin?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 4D.
What classification code is assigned to this device?
This device is registered under product classification code ITX.
Similar Classification Devices (ITX)
Other Devices by VIASONIX LTD
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