Organization name

GE Vingmed Ultrasound AS

SRN

NO-MF-000000553

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW027

  EUDAMED did not publish a description for this code.
• CW010

  The ultrasound unit is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

Primary placement in Norway; available across 32 countries total.

Trade name

Vivid Explorer

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00198953172384

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

08406821BUG0061173

Reference / catalog number

Vivid Explorer/TC001011

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Vivid Explorer is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid

Additional information URL

http://www.gehealthcare.com/DocumentationLibrary

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z11040102CARDIOLOGY ULTRASOUND SCANNERS

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.