Manufacturer

InTec PRODUCTS

ChinaLegal entities : InTec PRODUCTS, INC.

Markets : Belgium · Bulgaria · France · Germany · Greece · Italy · Netherlands · Portugal

EU representative : QbD RepS BV (Belgium)

16 categories, 37 models including 33 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
Coronavirus antigen (ag) - RT & POC	W0105090501	69361558COVID19-AG-BE**X5 ITP1601398/79 AQ+ COVID-19 Ag Rapid Test ITP160424 refs98/79 AQ+ COVID-19 Ag Rapid Test ITP1604498/79 AQ+ COVID-19 Ag Rapid Test ITP16044-TC25-98/79 Rapid SARS-CoV-2 Antigen Test ITP160103 refs98/79 1 other Rapid SARS-CoV-2 Antigen Test ITP1601398/79	– 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	ONE STEP Anti-Dengue (IgM & IgG) Tri-line Test ITP710023 refs98/79 One Step Dengue NS1 Ag Test ITP7100398/79 Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test ITP710044 refs98/79 Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test ITP7100598/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Rapid Flu A Test ITP08100198/79 Rapid Flu A/B Test ITP08100398/79 Rapid Flu B Test ITP08100298/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	ONE STEP Malaria(p.f.) Test ITP110022 refs98/79 ONE STEP Malaria(p.f/p.v) Tri-line Test ITP110032 refs98/79 Rapid Malaria Test (P.f/Pan) ITP110052 refs98/79	– 98/79	EUDAMED record Report an error
HCV antibody (total)	W0105020303	ITP01152-TC4098/79 ITP01153-TC1098/79 ITP01152-TC2598/79 (no longer marketed) ITP01153-TC4098/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
HIV multiple antibody	W0105030402	ITP02153-TC1098/79 ITP02153-TC4098/79 ITP02152-TC2598/79 (no longer marketed) ITP02152-TC4098/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	Rapid Anti-H.Pylori Test ITP100022 refs98/79 Rapid Anti-H.Pylori Test ITP102122 refs98/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	ONE STEP H. pylori Ag Test ITP100032 refs98/79 ONE STEP H. pylori Ag Test ITP1021398/79	– 98/79	EUDAMED record Report an error
Other multiple pathogens - RT & POC	W0105090699	COVID-19/FluA&B/RSV Ag Combo Rapid Test ITP18260398/79 Rapid Rota-Adenovirus Combo Test ITP1400398/79	– 98/79	EUDAMED record Report an error
Adenovirus	W0105040601	W0105040601 ITP1400298/79	– 98/79	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	Rapid Anti-TB (Mycobacterium Tuberculosis) Test ITP090022 refs98/79	– 98/79	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	AQ+Rapid SARS-CoV-19/ Flu Combo Test ITP160503 refs98/79	– 98/79	EUDAMED record Report an error
Hev antibody igm	W0105020505	Rapid Anti-HEV-IgM Test ITP0911012 refs98/79	– 98/79	EUDAMED record Report an error
Mycoplasma antibody assays	W0105010802	Rapid Mycoplasma Pneumoniae IgM test ITP1500198/79	– 98/79	EUDAMED record Report an error
Rotavirus	W0105040606	Rapid Rotavirus Test ITP1400198/79	– 98/79	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	ONE STEP Anti-TP (Treponema Pallidum/Syphilis) TEST ITP030042 refs98/79	– 98/79	EUDAMED record Report an error

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