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 - Sky Labs Inc.

Address:

#703 58 Pangyo-ro 255beon-gil

Seongnam-si

Gyeonggi-do 14521

South Korea

Authorised Representative/ UK Responsible Person
Name: UKCA Experts Ltd.
Address:

Dept 302 43 Owston Road Carcroft

Doncaster

DN6 8DA

England United Kingdom

Code/Term Type

Bedside heart rate monitor Bedside heart rate monitor Class IIa

Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder 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
Bedside heart rate monitor	Bedside heart rate monitor	Class IIa
Telemetric electrocardiographic ambulatory recorder	Telemetric electrocardiographic ambulatory recorder	Class IIa