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 - Andon Health Co Ltd

Address:

No 3 Jinping Street YaAn Road Nankai District

Tianjin

300190

China

Authorised Representative/ UK Responsible Person
Name: lotus global co ltd
Address:

23 Maine Street

Reading

Reading RG2 6AG

England United Kingdom

Code/Term Type

Glucose monitoring system IVD home-use Glucose monitoring system IVD home-use IVD Annex II List B

Automatic-inflation electronic sphygmomanometer portable arm/wrist Automatic-inflation electronic sphygmomanometer portable arm/wrist Class IIa

Pulse oximeter Pulse oximeter Class IIa

Red-light phototherapy unit professional Red-light phototherapy unit professional Class IIa

Infrared patient thermometer skin Infrared patient thermometer skin Class IIa

Glucose IVD reagent Glucose IVD reagent IVD Annex II List B

Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid IVD Devices for Self-Testing

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
Glucose monitoring system IVD home-use	Glucose monitoring system IVD home-use	IVD Annex II List B
Automatic-inflation electronic sphygmomanometer portable arm/wrist	Automatic-inflation electronic sphygmomanometer portable arm/wrist	Class IIa
Pulse oximeter	Pulse oximeter	Class IIa
Red-light phototherapy unit professional	Red-light phototherapy unit professional	Class IIa
Infrared patient thermometer skin	Infrared patient thermometer skin	Class IIa
Glucose IVD reagent	Glucose IVD reagent	IVD Annex II List B
Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid	Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid	IVD Devices for Self-Testing