KH Medical Co., Ltd.

SRN: KR-MF-000017883 · Jinwiseo-ro, Jinwi-myeon 201, 17712 Pyeongtaek-si, Gyeonggi-do, South Korea

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Basic UDI-DIs

Total Devices

On Market

Off Market

Certificates

Valid

Expiring < 6mo

Countries

Basic Information

Address: Jinwiseo-ro, Jinwi-myeon 201, 17712 Pyeongtaek-si, Gyeonggi-do, South Korea
Email: [email protected]
Phone: +82-31-647-0109
Website: www.khmedical.co.kr

Regulatory Overview

Regulation

Eu Ivdd 25

Eu Ivdr 3

Classification

Eu Ivd General 25

Eu Ivd Class A 3

Device Types

Certificate Health

No certificates registered for this manufacturer.

Device Portfolio

Name	Regulation	Classification	Market Status
BRUCELLA - NA REAGENTS	EU IVDD	Eu Ivd General	On Market
CHIKUNGUNYA VIRUS - NA REAGENTS	EU IVDD	Eu Ivd General	On Market
DENGUE VIRUS - NA REAGENTS	EU IVDD	Eu Ivd General	On Market
EBOLA (FILOVIRUS) - NA REAGENTS	EU IVDD	Eu Ivd General	On Market
HPV REAGENTS - OTHER	EU IVDD	Eu Ivd General	On Market
INFLUENZA & PARA INFLUENZA - NA REAGENTS	EU IVDD	Eu Ivd General	On Market
INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01]	EU IVDD	Eu Ivd General	On Market
LEISHMANIA	EU IVDD	Eu Ivd General	On Market
MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER	EU IVDD	Eu Ivd General	On Market
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER	EU IVDR	Eu Ivd Class A	On Market
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER	EU IVDR	Eu Ivd Class A	On Market
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER	EU IVDR	Eu Ivd Class A	On Market
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER	EU IVDR	Eu Ivd Class A	On Market
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS	EU IVDR	Eu Ivd Class A	On Market
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS	EU IVDR	Eu Ivd Class A	On Market
PLASMODIUM (MALARIA)	EU IVDD	Eu Ivd General	On Market
PLASMODIUM (MALARIA)	EU IVDD	Eu Ivd General	On Market
REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS	EU IVDR	Eu Ivd Class A	On Market
REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS	EU IVDR	Eu Ivd Class A	On Market
REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS	EU IVDR	Eu Ivd Class A	On Market
REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS	EU IVDR	Eu Ivd Class A	On Market
REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS	EU IVDR	Eu Ivd Class A	On Market
REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS	EU IVDR	Eu Ivd Class A	On Market
RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS	EU IVDD	Eu Ivd General	On Market
SALMONELLA ANTIGEN DETECTION	EU IVDD	Eu Ivd General	On Market
SHIGELLA - NA REAGENTS	EU IVDD	Eu Ivd General	On Market
VIROLOGY - NA REAGENTS - OTHER	EU IVDD	Eu Ivd General	On Market
VIROLOGY - NA REAGENTS - OTHER	EU IVDD	Eu Ivd General	On Market
VIROLOGY - NA REAGENTS - OTHER	EU IVDD	Eu Ivd General	On Market
VIROLOGY - NA REAGENTS - OTHER	EU IVDD	Eu Ivd General	On Market
VIROLOGY - NA REAGENTS - OTHER	EU IVDD	Eu Ivd General	On Market
VIROLOGY - NA REAGENTS - OTHER	EU IVDD	Eu Ivd General	On Market
VIROLOGY - NA REAGENTS - OTHER	EU IVDD	Eu Ivd General	On Market
VIROLOGY - NA REAGENTS - OTHER	EU IVDD	Eu Ivd General	On Market
VIROLOGY - NA REAGENTS - OTHER	EU IVDD	Eu Ivd General	On Market
VIROLOGY - NA REAGENTS - OTHER	EU IVDD	Eu Ivd General	On Market
WEST NILE VIRUS - NA REAGENT	EU IVDD	Eu Ivd General	On Market