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 - Osypka Medical GmbH

Address:

Osypka Medical GmbH

Albert-Einstein-Str. 3 Berlin

Berlin

Berlin 12489

Germany

Authorised Representative/ UK Responsible Person
Name: Dot Medical Ltd
Address:

Silk Point Queens Avenue

Macclesfield

Cheshire SK10 2BB

England United Kingdom

Code/Term Type

Impedance cardiac output unit Impedance cardiac output unit Class IIb

External pacemaker epicardial pacing External pacemaker epicardial pacing Class IIb

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
Impedance cardiac output unit	Impedance cardiac output unit	Class IIb
External pacemaker epicardial pacing	External pacemaker epicardial pacing	Class IIb