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 - NanoEnTek Inc.

Address:

12 F 5 Digital ro 26-gil Guro-gu

Seoul

08389

South Korea

Authorised Representative/ UK Responsible Person
Name: MT Promedt Consulting Ltd
Address:

Beaver House 23-38 Hythe Bridge Street

Oxford

OX1 2EP

England United Kingdom

Code/Term Type

Fluorescent immunoassay analyser IVD point-of-care Fluorescent immunoassay analyser IVD point-of-care Class A

White blood cell count IVD kit cell count White blood cell count IVD kit cell count IVD General

CD34 cell marker IVD antibody CD34 cell marker IVD antibody IVD General

Haematological cell analyser IVD Haematological cell analyser IVD Class A

Microscope counting chamber IVD Microscope counting chamber IVD Class A

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
Fluorescent immunoassay analyser IVD point-of-care	Fluorescent immunoassay analyser IVD point-of-care	Class A
White blood cell count IVD kit cell count	White blood cell count IVD kit cell count	IVD General
CD34 cell marker IVD antibody	CD34 cell marker IVD antibody	IVD General
Haematological cell analyser IVD	Haematological cell analyser IVD	Class A
Microscope counting chamber IVD	Microscope counting chamber IVD	Class A