Public Access Database for Medical Device Registration

Registration does not represent any form of accreditation, certification or approval by the UK Competent Authority(MHRA)
Where a conformity assessment certificate is listed as expired, existing products already placed on the market prior to the expiry may not be affected by this expiry and can continue to be used. This expiry stops new products being placed on the market until there is a new certificate of conformity

Manufacturer's By Name

By Device

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Manufacturer's Devices - KOELIS

Address:

16 chemin du Vieux Chêne

MEYLAN

38240

France

Authorised Representative/ UK Responsible Person
Name: Compliance Solutions (Lifesciences) Ltd
Address:

Suite 10 Dunswood House 1 Dunswood Road

Cumbernauld

Glasgow

G67 3EN

United Kingdom

Code/Term Type

General-purpose ultrasound imaging system General-purpose ultrasound imaging system Class IIa

Surgical instrument assist arm system manually-adjusted Surgical instrument assist arm system manually-adjusted Class I

Needle guide reusable Needle guide reusable Class I

Image segmentation application software Image segmentation application software Class I

Contact details

Freedom of information

0203 080 7272 (manned 10:00-16:00 hours working days) device.registrations@mhra.gov.uk

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Code/Term		Type
General-purpose ultrasound imaging system	General-purpose ultrasound imaging system	Class IIa
Surgical instrument assist arm system manually-adjusted	Surgical instrument assist arm system manually-adjusted	Class I
Needle guide reusable	Needle guide reusable	Class I
Image segmentation application software	Image segmentation application software	Class I