Manufacturer

KH Medical

South KoreaLegal entities : KH Medical Co., Ltd.

Markets : Germany · Italy

Approvals : EU – class A

EU representative : Medical Technology Promedt Consulting GmbH (Germany)

Website info@khmedical.co.kr

19 categories, 31 models including 31 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Virology - NA reagents - other	W0105040599	RADI CDZ Virus Detection Kit98/79 RADI COVID-19 Detection Kit98/79 RADI FAST COVID-19 Detection Kit98/79 RADI FAST Mpox Detection Kit RV01598/79 RADI Flu-SC2 Detection Kit98/79 6 others RADI Monkeypox Detection Kit98/79 RADI MTB Detection Kit98/79 RADI Rift Valley Fever Virus Detection Kit98/79 RADI STI-10 Detection Kit98/79 RADI Vibrio cholera Detection KIT98/79 RADI Yellow Fever Virus Detection Kit98/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	RADI PCR RADICHAMP	A IVDR	EUDAMED record Report an error
Plasmodium (malaria)	W0105050209	CHAMP Malaria P.f Kit98/79 RADI Malaria Detection Kit98/79	– 98/79	EUDAMED record Report an error
Brucella - NA reagents	W0105011601	RADI Brucella spp Detection KIT98/79	– 98/79	EUDAMED record Report an error
Chikungunya virus - NA reagents	W0105040525	RADI Chikungunya Detection Kit98/79	– 98/79	EUDAMED record Report an error
Dengue virus - NA reagents	W0105040511	RADI Dengue Virus Detection Kit98/79	– 98/79	EUDAMED record Report an error
DNA genomic preparation devices	W02050106	RADIONE2 refs	A IVDR	EUDAMED record Report an error
Ebola (filovirus) - NA reagents	W0105040528	RADI Ebola Virus Detection Kit98/79	– 98/79	EUDAMED record Report an error
HPV reagents - other	W0105041099	RADI Human Papillomavirus Detection Kit98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza - NA reagents	W0105040504	RADI FAST Influenza A/B Detection Kit98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents	W0105070304	RADI FAST Flu-SC2-RSV Detection Kit98/79	– 98/79	EUDAMED record Report an error
Leishmania	W0105050205	RADI Kala-azar (Leishmania) Detection KIT98/79	– 98/79	EUDAMED record Report an error
Multiple viruses - multiplex assays - other	W0105070399	RADI FAST Flu-SC2 Detection Kit98/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - other	W02050199	TTÅniKoReader® KM102	A IVDR	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	RADIPREP3 refs	A IVDR	EUDAMED record Report an error
Respiratory syncytial virus (rsv) - NA reagents	W0105040505	RADI FAST RSV A/B Detection Kit98/79	– 98/79	EUDAMED record Report an error
Salmonella antigen detection	W0105011001	RADI Salmonella spp Detection KIT98/79	– 98/79	EUDAMED record Report an error
Shigella - NA reagents	W0105011614	RADI Shigella spp Detection KIT98/79	– 98/79	EUDAMED record Report an error
West nile virus - NA reagent	W0105040526	RADI West nile virus Detection Kit98/79	– 98/79	EUDAMED record Report an error

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