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 AG

Address:

Earl-H-Wood-Strasse 1

Rheinfelden

79618

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

Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Class III

Electrical-only medical device connection cable reusable Electrical-only medical device connection cable reusable Class I

Electrical-only medical device connection cable single-use Electrical-only medical device connection cable single-use Class I

Neural-tissue electrical stimulation lead adaptor Neural-tissue electrical stimulation lead adaptor

Transthoracic pacing lead Transthoracic pacing lead Class III

Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Class III

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
Cardiac radio-frequency ablation system catheter	Cardiac radio-frequency ablation system catheter	Class III
Electrical-only medical device connection cable reusable	Electrical-only medical device connection cable reusable	Class I
Electrical-only medical device connection cable single-use	Electrical-only medical device connection cable single-use	Class I
Neural-tissue electrical stimulation lead adaptor	Neural-tissue electrical stimulation lead adaptor
Transthoracic pacing lead	Transthoracic pacing lead	Class III
Cardiac valvuloplasty catheter	Cardiac valvuloplasty catheter	Class III