Manufacturer

Labnovation

ChinaLegal entities : Labnovation Technologies, Inc.

Markets : Germany

Approvals : EU – class A

EU representative : MedNet EC-REP GmbH (Germany)

Website info@labnovation.com

13 categories, 23 models including 23 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
Bacteriology - RT & POC - other	W0105090199	Candida Albicans/Trichomonas vaginalis Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 Neisseria Gonorrhoeae Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 Vibrio Cholerae O1/O139 Antigen Rapid Test kit (Immunochromatography) 20 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Dengue IgG/IgM Antibody Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 Dengue NS1 Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 Dengue NS1&IgG/lgM Rapid Test (Immunochromatography) 20 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Virology - RT & POC - other	W0105099099	Human Papillomavirus (HPV) Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 SARS-CoV-2/Flu A/Flu B/RSV/ADV Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 SARS-CoV-2/Flu A/Flu B/RSV/ADV/MP Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Glycosilated hemoglobin devices	W0201060101	Automated HbA1c Analyzer2 refs POCT HbA1c Analyzer3 refs	A IVDR	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	H. Pylori Antibody Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 H. Pylori Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
High performance liquid chromatography systems - consumables	W0201050285	Chromatography Column L-560101C98/79 Chromatography Column L-600104C98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria P.f (HRP-2) Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 Malaria P.f (HRP-2)/P.v (LDH)/Pan (LDH) Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	SARS-CoV-2 Antigen and Influenza A/B Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
High performance liquid chromatography systems	W0201050201	Fully Automated HbA1c Analyzer6 refs	A IVDR	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza A/B Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Monkeypox virus / mpox RT & POC	W0105099008	Monkeypox Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	Treponema Pallidum Antibody Rapid Test kit (Immunochromatography) 20 Tests/Kit98/79	– 98/79	EUDAMED record Report an error

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