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 - CU Medical Systems Inc.

Address:

130-1 Donghwagongdan-ro Munmak-eup Wonjusi

Gangwon-do

26365

South Korea

Authorised Representative/ UK Responsible Person
Name: MDSS-UK RP LIMITED
Address:

6 Wilmslow Road Rusholme

Manchester

M14 5TP

England United Kingdom

Code/Term Type

Physiologic-monitoring defibrillation system Physiologic-monitoring defibrillation system Class IIb

Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Class IIb

Non-rechargeable public semi-automated external defibrillator Non-rechargeable public semi-automated external defibrillator Class IIb

External defibrillator electrode paediatric single-use External defibrillator electrode paediatric single-use Class IIb

External defibrillator electrode adult single-use External defibrillator electrode adult single-use 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
Physiologic-monitoring defibrillation system	Physiologic-monitoring defibrillation system	Class IIb
Non-rechargeable public automated external defibrillator	Non-rechargeable public automated external defibrillator	Class IIb
Non-rechargeable public semi-automated external defibrillator	Non-rechargeable public semi-automated external defibrillator	Class IIb
External defibrillator electrode paediatric single-use	External defibrillator electrode paediatric single-use	Class IIb
External defibrillator electrode adult single-use	External defibrillator electrode adult single-use	Class IIb