Statistics for GE Vingmed Ultrasound AS

39Total Devices

14Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

4Countries

Certificate health for GE Vingmed Ultrasound AS

No certificates registered for this manufacturer.

Devices by risk class

Device catalog for GE Vingmed Ultrasound AS

Showing 1–25 of 39 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
KN100107	`KN100107`	`00840682115582`	1	On the market
KN100106	`KN100106`	`00840682115735`	1	On the market
KN100110	`KN100110`	`00840682115681`	1	On the market
KN100121	`KN100121`	`00840682115636`	1	On the market
KN100122	`KN100122`	`00840682115728`	1	On the market

Device families (Basic UDI-DI) of GE Vingmed Ultrasound AS

Showing 1–8 of 8 device families.

Market presence of GE Vingmed Ultrasound AS

Devices placed in 4 countries

Norway28
Austria4
Germany4
France3

EUDAMED update: Jan 13, 2025

GE Vingmed Ultrasound AS

NO-MF-000000553

Active

Address: Strandpromenaden, 45 3191 HORTEN
Role: Manufacturer
Date of registration: Jan 7, 2021
Country: NO Norway

Certificate health for GE Vingmed Ultrasound AS

No certificates registered for this manufacturer.

About GE Vingmed Ultrasound AS

SRN: NO-MF-000000553
Role: Manufacturer
Country: Norway
Organization name: GE Vingmed Ultrasound AS
EU VAT number: 938937583MVA
Trade register: 938937583
Date of registration: Jan 7, 2021

Contact details for GE Vingmed Ultrasound AS

Address: 45, STRANDPROMENADEN 3191 HORTEN NORWAY
Email: eudamed@gehealthcare.com

Validator

Name: The Norwegian Medical Products Agency
SRN: NO-CA-032
Phone: +47 22 89 77 00
Email: Meddev-no@noma.no

Officers and regulatory representatives of GE Vingmed Ultrasound AS

THOLLEFSEN Jan Tore
15.3 (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; 15.3 (e) investigational devices conform to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject.
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RONANDER Jon
15.3 (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; 15.3 (c) the post-market surveillance obligations are complied with in accordance with EU MDR Article 10(10); 15.3 (d) the reporting obligations referred to in EU MDR Articles 87 to 91 are fulfilled;
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