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 - Acutus Medical Inc.

Address:

2210 Faraday Avenue Suite 100

Carlsbad

California 92008

United States

Authorised Representative/ UK Responsible Person
Name: Acutus Medical UK Limited
Address:

Hill House 1 Little New Street

London

EC1A 3TR

England United Kingdom

Code/Term Type

Cardiac mapping/ultrasound imaging catheter Cardiac mapping/ultrasound imaging catheter Class III

Cardiac mapping system Cardiac mapping system Class IIb

Cardiac transseptal access set Cardiac transseptal access set Class III

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

Catheter-tip-to-tissue contact monitor Catheter-tip-to-tissue contact monitor Class IIb

Vascular catheter introduction set nonimplantable Vascular catheter introduction set nonimplantable Class III

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

Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Class III

Cardiac mapping system reference patch Cardiac mapping system reference patch Class I

Vascular guide-catheter single-use Vascular guide-catheter single-use 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 mapping/ultrasound imaging catheter	Cardiac mapping/ultrasound imaging catheter	Class III
Cardiac mapping system	Cardiac mapping system	Class IIb
Cardiac transseptal access set	Cardiac transseptal access set	Class III
Electrical-only medical device connection cable reusable	Electrical-only medical device connection cable reusable	Class I
Catheter-tip-to-tissue contact monitor	Catheter-tip-to-tissue contact monitor	Class IIb
Vascular catheter introduction set nonimplantable	Vascular catheter introduction set nonimplantable	Class III
Cardiac radio-frequency ablation system catheter	Cardiac radio-frequency ablation system catheter	Class III
Cardiac transseptal access electrosurgical dilator/needle	Cardiac transseptal access electrosurgical dilator/needle	Class III
Cardiac mapping system reference patch	Cardiac mapping system reference patch	Class I
Vascular guide-catheter single-use	Vascular guide-catheter single-use	Class III