Manufacturer

Medotexbio

ChinaLegal entities : Medotex Biotech (HangZhou) Co., Ltd.

Markets : Germany · Greece · Spain

Approvals : EU – class B, C

EU representative : Llins Service & Consulting GmbH (Germany)

Website

31 categories, 72 models including 72 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
Other multiple pathogens - RT & POC	W0105090699	10-in-1 Respiratory Antigen Combo Rapid Test RVC-5105a-25M 12-in-1 Respiratory Antigen Combo Rapid Test98/79 5-in-1 Respiratory Antigen Combo Rapid Test 6-in-1 Respiratory Antigen Combo Rapid Test98/79 8-in-1 Respiratory Antigen Combo Rapid Test RVC-585b98/79 12 others 8-in-1 Respiratory Antigen Combo Rapid Test RVC-585b-25M Flu A&B/SARS-CoV-2/RSV Antigen Combo Test Flu A&B/SARS-CoV-2/RSV/ADV Antigen Combo Test Flu A&B/SARS-CoV-2/RSV/ADV Antigen Combo Test RVC-555b98/79 Flu A&B/SARS-CoV-2/RSV/ADV/hPIV Antigen Combo Rapid Test98/79 Flu A&B/SARS-CoV-2/RSV/ADV/MP Antigen Combo Rapid Test98/79 Flu A&B/SARS-CoV-2/RSV/hMPV Antigen Combo Test98/79 Norovirus/Rotavirus/Adenovirus Antigen Combo Rapid Test GIC-635a98/79 Respiratory Multiple Antigen Combo Test RVC-5X598/79 Rotavirus/Adenovirus Combo Rapid Test RAC-622a98/79 RVC-5105a98/79 RVC-585c98/79	B IVDR, 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Dengue (DENV) IgG/IgM and NS1 Combo Rapid Test Dengue (DENV) NS1 Ag Rapid Test Dengue IgG/IgM and NS1 Combo Rapid Test DENC-435a98/79 Dengue IgG/IgM Rapid Test DEN-422a98/79 Dengue IgG/IgM Rapid Test DEN-422a-25M 1 other Dengue NS1 Ag Rapid Test DEN-402b98/79	B, C IVDR, 98/79	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	Gardnerella Vaginalis Antigen Rapid Test Mycoplasma pneumoniae Antigen Rapid Test MP-502b98/79 Salmonella Typhi Antigen Test98/79 TYP-422a98/79	B IVDR, 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	H. pylori Antigen Rapid Test HP-602a98/79 H. pylori Antibody Rapid Test HP-402b98/79 Medotex H. pylori Antigen Rapid Test HP-602a Medotex H. pylori Antibody Rapid Test HP-402b	B IVDR, 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria P.f. Rapid Test MAL-402b Malaria P.f./P.v. Rapid Test MALV-422b Malaria P.f./Pan Rapid Test MALN-422b MALV-422b98/79	C IVDR, 98/79	EUDAMED record Report an error
Virology - RT & POC - other	W0105099099	Adenovirus (ADV) Antigen Rapid Test Adenovirus Antigen Rapid Test ADV-502b98/79 Hantavirus IgG/IgM Rapid Test HNTV-422a98/79 Human Metapneumovirus (hMPV) Antigen Rapid Test	B IVDR, 98/79	EUDAMED record Report an error
Hepatitis viruses - RT & POC - other	W0105090299	HAV IgG Rapid Test HAV-402a98/79 HAV IgG/IgM Rapid Test HAV-422a98/79 HAV IgM Rapid Test HAVM-402a98/79	– 98/79	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	Flu A&B/SARS-CoV-2 Antigen Combo Test RVC-532b2 refs RVC-535b	B IVDR, 98/79	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	Medotex SARS-CoV-2 Antigen Rapid Test 40 Tests98/79 SARS-CoV-2 Antigen Rapid Test	B IVDR, 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	Respiratory Syncytial Virus (RSV) Antigen Rapid Test RSV-502b RSV Antigen Rapid Test RSV-502b98/79	B IVDR, 98/79	EUDAMED record Report an error
Streptococcal direct antigen detection	W0105011101	Group A Streptococcus (Strep A) Antigen Rapid Test Streptococcus pneumoniae (Spn) Antigen Rapid Test	B IVDR	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	Syphilis Rapid Test SYP-401a Syphilis Rapid Test SYP-402b98/79	C IVDR, 98/79	EUDAMED record Report an error
Zika virus	W0105040630	Zika IgG/IgM Rapid Test ZIKA-422a98/79 Zika NS1 Rapid Test98/79	– 98/79	EUDAMED record Report an error
Adenovirus	W0105040601	Adenovirus Antigen Rapid Test (Feces) ADV-602a98/79	– 98/79	EUDAMED record Report an error
Bordetella pertussis / parapertussis	W0105011707	Bordetella pertussis(BP) Antigen Rapid Test98/79	– 98/79	EUDAMED record Report an error
C.difficile GDH detection	W0105011801	Clostridium difficile GDH Rapid Test DGDH-602a98/79	– 98/79	EUDAMED record Report an error
C.difficile toxin a/b detection	W0105011802	Clostridium difficile Toxin A &Toxin B Combo Rapid Test DTAB-622a98/79	– 98/79	EUDAMED record Report an error
Campylobacter direct antigen detection	W0105011401	Campylobacter Rapid Test CAMP-602a98/79	– 98/79	EUDAMED record Report an error
Candida albicans	W0105060302	Candida Albicans Antigen Rapid Test CA-502a	B IVDR	EUDAMED record Report an error
Chikungunya virus	W0105040625	Chikungunya IgG/IgM Rapid Test CHI-422a98/79	– 98/79	EUDAMED record Report an error
Chlamydia pneumoniae antigen detection	W0105010112	Chlamydia pneumoniae(CP) Antigen Rapid Test98/79	– 98/79	EUDAMED record Report an error
Ebola (filovirus)	W0105040627	Ebola Antigen Rapid Test EBOV-402a98/79	– 98/79	EUDAMED record Report an error
Gonococcal antigen detection	W0105010201	Gonorrhea Rapid Test98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza	W0105040604	Parainfluenza(hPIV) Antigen Rapid Test98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza A/B Antigen Rapid Test FLU-522b2 refs	B IVDR, 98/79	EUDAMED record Report an error
Leishmania	W0105050205	Leishmania IgG/IgM Rapid Test LEI-422a98/79	– 98/79	EUDAMED record Report an error
Mycoplasma antibody assays	W0105010802	Mycoplasma pneumoniae IgM Rapid Test MPM-402a98/79	– 98/79	EUDAMED record Report an error
Mycoplasma antigen detection	W0105010801	Mycoplasma Pneumoniae Antigen Rapid Test MP-502b	B IVDR	EUDAMED record Report an error
Norovirus	W0105040616	Norovirus Antigen Rapid Test NORO-622a98/79	– 98/79	EUDAMED record Report an error
Parasites - RT & POC - other	W0105090499	Filariasis IgG/IgM Rapid Test98/79	– 98/79	EUDAMED record Report an error
Rotavirus	W0105040606	Rotavirus Rapid Test ROTA-602a98/79	– 98/79	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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