Telemetric electrocardiographic ambulatory recorder - UK MHRA Medical Device Registration

Telemetric electrocardiographic ambulatory recorder is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 163200. The device is manufactured by Sky Labs Inc. from South Korea, classified as General Medical Device. The authorized representative in the UK is UKCA Experts Ltd..

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Telemetric electrocardiographic ambulatory recorder

MHRA Device ID: 163200•Ref: 163200

Device Type

General Medical Device

Devices

Telemetric electrocardiographic ambulatory recorder

Type

Class IIa

Date Registered

Apr 11, 2024

Last Updated

Nov 7, 2023

Manufacturer Information

Name

Sky Labs Inc.

Address

#703, 58, Pangyo-ro 255beon-gil

Seongnam-si, Gyeonggi-do, South Korea

Created Date

Dec 15, 2021

Authorized Representative

Name

UKCA Experts Ltd.

Relationship Type

UK Responsible Person

Address

Dept 302, 43 Owston Road Carcroft

Doncaster, England, United Kingdom

Postcode: DN6 8DA

DJ Fang

MedTech Regulatory Expert

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Other Products from Sky Labs Inc. (1)

Bedside heart rate monitor

Type: General Medical Device

Registered: Apr 11, 2024

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Telemetric electrocardiographic ambulatory recorder - UK MHRA Medical Device Registration

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Date Registered

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Created Date

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DJ Fang

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