Manufacturer

Clongene

ChinaLegal entities : Hangzhou Clongene Biotech Co., Ltd.

First countries of placing on the market declared in EUDAMED : Germany, Hungary

EU representative : HUMISS TRADING S. L. (Spain)

20 categories, 65 models including 65 on the market, 1 country

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 - RT & POC - other	W0105099099	Adenovirus Antigen Rapid Test (Feces) IAD6001 IAD600298/79 Adenovirus Antigen Rapid Test (Swab) IADq001, IADq002, IADq00898/79 Chikungunya IgG/IgM Rapid Test ICHI421298/79 Chikungunya IgM Rapid Test ICHI400298/79 COVID-19 Antigen Rapid Test Cassette2 refs98/79 19 others COVID-19 Antigen Rapid Test Cassette (Nasal Swab) ICOVu00298/79 COVID-19 Antigen Rapid Test Cassette (Saliva) ICOV700298/79 COVID-19 IgG/IgM Rapid Test ICOV421298/79 COVID-19 Neutralization Antibody Rapid Test Cassette (WB/S/P) ICNA400298/79 COVID-19/Influenza A+B Antigen Combo Rapid Test ICFq312, ICFq31898/79 COVID-19/Influenza A+B/HPIV/RSV/AdV/MP Antigen Combo Rapid Test IRTan74598/79 COVID-19/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test IGMq52598/79 COVID-19/Influenza A+B/RSV/AdV/MP Antigen Combo Rapid Test IHFNn63598/79 COVID-19/Influenza A+B/RSV/MP Antigen Combo Rapid Test IGLn52598/79 COVID-19/RSV/Influenza A+B Antigen Combo Rapid Test IHFq42598/79 HMPV Antigen Rapid Test IHMPn002 IHMPn00898/79 HPIV Antigen Rapid Test IHPIn002 IHPIn00898/79 HPV 16/18 Antigen Rapid Test IHPVd2a1 IHPVd2a298/79 HSV 1/2 IgG/IgM Rapid Test IHSV44a298/79 Norovirus Antigen Rapid Test Cassette (Feces) INV621298/79 Rotavirus Antigen Rapid Test IROT6001, IROT600298/79 Rotavirus/Adenovirus Antigen Combo Rapid Test Cassette (Feces) IRA620598/79 Rotavirus/Adenovirus Antigen Triline Rapid Test IRA6212, IRA621898/79 Rotavirus/Adenovirus/Norovirus Antigen Combo Rapid Test Cassette (Feces) IID642598/79	– 98/79	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	Brucellosis IgG/IgM Rapid Test IBRU4211, IBRU421298/79 Leptospira IgG/IgM Rapid Test ILEP4211, ILEP421298/79 M. tuberculosis Antigen Rapid Test ITBGa002 ITBGa00898/79 Mycoplasma pneumoniae Antigen Rapid Test IMPGp002 IMPGp00898/79 Mycoplasma Pneumoniae IgM Rapid Test IMP4001, IMP400298/79 7 others S.Typhi Antigen Rapid Test ISTG600298/79 Scrub Typhus IgG/IgM Rapid Test / Rickettsia IgG/IgM Rapid Test ISTA421298/79 Tuberculosis Rapid Test ITB4001, ITB400298/79 Typhoid IgG/IgM Rapid Test (S/P) ISTB321298/79 Typhoid IgG/IgM Rapid Test Cassette (WB/S/P) ISTB421298/79 Vibrio Cholerae O1 Antigen Rapid Test IVCA600298/79 Vibrio Cholerae O1/O139 Antigen Rapid Test Cassette (Feces) IVC621298/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria P.f Antigen Rapid Test Cassette (WB) IPFGi00298/79 Malaria P.f/P.v Antigen Rapid Test Cassette (WB) IFVGi2198/79 Malaria P.f/Pan Antigen Rapid Test Cassette (WB) IFPGi212, IFPGi21898/79 Malaria Pan Antigen Rapid Test Cassette (WB) IPANi00298/79	– 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Dengue IgG/IgM Rapid Test Cassette (WB/S/P) IDAB421298/79 Dengue IgG/IgM-NS1 Combo Rapid Test Cassette (WB/S/P) IDEN432598/79 Dengue NS1 Antigen Rapid Tests IDAG4001, IDAG400298/79	– 98/79	EUDAMED record Report an error
Parasites - RT & POC - other	W0105090499	Filariasis Antigen Rapid Test IFAG400298/79 Filariasis IgG/IgM Rapid Test IFIL421298/79 Leishmania IgG/IgM Rapid Test ILEI421298/79	– 98/79	EUDAMED record Report an error
D-dimer - RT & POC	W0103020803	D-Dimer FIA CfDDg00298/79 D-Dimer Rapid Test CDDg00298/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	H.pylori Antibody Rapid Tests IHPB4001, IHPB400298/79 H.pylori Antigen Rapid Test Cassette (Feces) IrHPG600298/79	– 98/79	EUDAMED record Report an error
Hepatitis viruses - RT & POC - other	W0105090299	HAV IgG/IgM Rapid Test IHAV4211, IHAV421298/79 HAV IgM Rapid Tests IHAV4001 IHAV400298/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents	W0105070304	Influenza A/B & RSV RT-PCR Test Kit IRP53Na98/79 SARS-CoV-2 & Influenza A/B RT-PCR Test Kit IID53Na98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza A+B Rapid Test IFLUn212, IFLUn21898/79	– 98/79	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	IL-6 FIA YfILS400298/79	– 98/79	EUDAMED record Report an error
Legionella - RT & POC	W0105090108	Legionella pneumophila Antigen Rapid Test ILP100298/79	– 98/79	EUDAMED record Report an error
Monkeypox virus / mpox - NA reagent	W0105040532	Monkeypox Virus PCR Test Kit IMPX00Na98/79	– 98/79	EUDAMED record Report an error
Monkeypox virus / mpox RT & POC	W0105099008	Monkeypox Virus Antigen Rapid Test IMPX000298/79	– 98/79	EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents	W0105041003	HPV 18 High-Risk with 16/18 Genotyping PCR Test Kit IHPVk0Ns98/79	– 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	RSV Antigen Rapid Test Cassette (Swab) IRSVn002, IRSVn00898/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	Strep A Rapid Tests ISAp001 ISAp002 ISAp00898/79	– 98/79	EUDAMED record Report an error
Strep. pneumoniae - RT & POC	W0105090109	Streptococcus pneumoniae Antigen Rapid Test ISP100298/79	– 98/79	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	Syphilis Rapid Tests ITP4001, ITP400298/79	– 98/79	EUDAMED record Report an error
Virology - NA reagents - other	W0105040599	SARS-CoV-2 Nucleic Acid RT-PCR Test Kit ICOV52Nb, ICOV52Na98/79	– 98/79	EUDAMED record Report an error

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