GUDIDData
gudid Primary ID: 11916

SonoTT FlowLab (UDI 11916)

Manufactured by em-tec GmbH

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SonoTT FlowLab - Primary ID 11916

Device Regulatory Overview

The SonoTT FlowLab (Model/Catalog Number: 11916) is a medical device manufactured by em-tec GmbH. This product is indexed under FDA Product Code / Category Classification DPW within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
11916
Product Code / EMDN
DPW
Device Name
The SonoTT FlowLab is used for the volumetric measurement of liquid flowing through tubing systems (in combination with the SonoTT Clamp-On Transducer), to measure blood volume flow (in combination with the SonoTT Vascular Probe) and flow velocity in arteries and veins (in combination with the SonoTT Pulse Wave Doppler Probe). The measurement principle is the ultrasound transit-time and Doppler method.
Database Sync Date
2026-08-09 09:11:43

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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Frequently Asked Questions

Who is the primary manufacturer of SonoTT FlowLab?

The registered manufacturer of record for SonoTT FlowLab is em-tec GmbH.

What is the Primary UDI-DI identifier for SonoTT FlowLab?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 11916.

What classification code is assigned to this device?

This device is registered under product classification code DPW.

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