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 - Shenzhen Changke Connect Electronics Co. Ltd.

Address:

A2-4th floor of factory building No.87 of Hengping Road Baoan Community Yuanshan Street

Longgang District

Shenzhen

518115

China

Authorised Representative/ UK Responsible Person
Name: Wellkang Ltd
Address:

Enterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland

BT48 8SE

Northern Ireland United Kingdom

Code/Term Type

Electrocardiographic lead set single-use Electrocardiographic lead set single-use Class I

Electrocardiographic lead set reusable Electrocardiographic lead set reusable Class I

Blood pressure cuff reusable Blood pressure cuff reusable Class I

Neurophysiologic monitoring system Neurophysiologic monitoring system Class I

Pulse oximetry telemetric monitoring system Pulse oximetry telemetric monitoring system Conformity Assessment Certificate Expired Class IIa

General-purpose patient temperature probe reusable General-purpose patient temperature probe reusable Conformity Assessment Certificate Expired Class IIa

General-purpose patient temperature probe single-use General-purpose patient temperature probe single-use Conformity Assessment Certificate Expired Class IIa

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
Electrocardiographic lead set single-use	Electrocardiographic lead set single-use	Class I
Electrocardiographic lead set reusable	Electrocardiographic lead set reusable	Class I
Blood pressure cuff reusable	Blood pressure cuff reusable	Class I
Neurophysiologic monitoring system	Neurophysiologic monitoring system	Class I
Pulse oximetry telemetric monitoring system	Pulse oximetry telemetric monitoring system Conformity Assessment Certificate Expired	Class IIa
General-purpose patient temperature probe reusable	General-purpose patient temperature probe reusable Conformity Assessment Certificate Expired	Class IIa
General-purpose patient temperature probe single-use	General-purpose patient temperature probe single-use Conformity Assessment Certificate Expired	Class IIa