Manufacturer

Orgentec

GermanyLegal entities : ORGENTEC Diagnostika GmbH

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

36 categories, 47 models including 47 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
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	Alegria Alegria 2 Alegria Negative Control Alegria Positive Control	A IVDR	EUDAMED record Report an error
Mycoplasma antibody assays	W0105010802	Anti-Mycoplasma pneumoniae IgA ORG 915A98/79 Anti-Mycoplasma pneumoniae IgG ORG 915G98/79 Anti-Mycoplasma pneumoniae IgM Abs.98/79	– 98/79	EUDAMED record Report an error
Bordetella pertussis / parapertussis	W0105011707	Anti-B. pertussis Toxin IgA ORG 916A98/79 Anti-B. pertussis Toxin IgG ORG 916G98/79	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	Anti-Helicobacter pylori IgA ORG 917A98/79 Anti-Helicobacter pylori IgG ORG 917G98/79	– 98/79	EUDAMED record Report an error
Lyme antibody igg	W0105010603	Anti-Borrelia IgG98/79 Anti-Borrelia IgG Liquor98/79	– 98/79	EUDAMED record Report an error
Lyme antibody igm	W0105010604	Anti-Borrelia IgM Abs.98/79 Anti-Borrelia IgM Liquor98/79	– 98/79	EUDAMED record Report an error
Parvovirus b 19	W0105040609	Anti-Parvovirus B19 IgG98/79 Anti-Parvovirus B19 IgM Abs.98/79	– 98/79	EUDAMED record Report an error
Yersinia	W0105011706	Anti-Yersinia IgA ORG 913A98/79 Anti-Yersinia IgG ORG 913G98/79	– 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - consumables	W0201020185	Alegria Automation Tips Alegria 300 μL Automation Tips	A IVDR	EUDAMED record Report an error
Chlamydia pneumoniae antibody iga	W0105010114	Anti-Chlamydia pneumoniae IgA ORG 907A98/79	– 98/79	EUDAMED record Report an error
Chlamydia pneumoniae antibody igg	W0105010115	Anti-Chlamydia pneumoniae IgG ORG 907G98/79	– 98/79	EUDAMED record Report an error
Chlamydia pneumoniae antibody igm	W0105010116	Anti-Chlamydia pneumoniae IgM Abs.98/79	– 98/79	EUDAMED record Report an error
Chlamydia trachomatis antibody iga	W0105010109	Anti-Chlamydia trachomatis IgA ORG 906A98/79	– 98/79	EUDAMED record Report an error
Chlamydia trachomatis antibody igg	W0105010110	Anti-Chlamydia trachomatis IgG ORG 906G98/79	– 98/79	EUDAMED record Report an error
Chlamydia trachomatis antibody igm	W0105010111	Anti-Chlamydia trachomatis IgM Abs.98/79	– 98/79	EUDAMED record Report an error
Ebv antibodies - other	W010504040199	Anti-EBV (ZEBRA) IgM98/79	– 98/79	EUDAMED record Report an error
Ebv ebna igg	W010504040106	Anti-EBV (EBNA-1) IgG98/79	– 98/79	EUDAMED record Report an error
Ebv vca igg	W010504040105	Anti-EBV (VCA) IgG ORG 901G98/79	– 98/79	EUDAMED record Report an error
Ebv vca igm	W010504040104	Anti-EBV (VCA) IgM Abs.98/79	– 98/79	EUDAMED record Report an error
Faeces collection devices	W05019001	Stool Extraction Tubes ORG 282	A IVDR	EUDAMED record Report an error
Hev antibody igg	W0105020504	Anti-Hepatitis E Virus IgG ORG 921G98/79	– 98/79	EUDAMED record Report an error
Hev antibody igm	W0105020505	Anti-Hepatitis E Virus IgM Abs.98/79	– 98/79	EUDAMED record Report an error
Hsv 1 igg	W0105040306	Anti-HSV-1 IgG98/79	– 98/79	EUDAMED record Report an error
Hsv 1 igm	W0105040307	Anti-HSV-1 IgM Abs.98/79	– 98/79	EUDAMED record Report an error
Hsv 1+2 igg	W0105040303	Anti-HSV-1/2 IgG98/79	– 98/79	EUDAMED record Report an error
Hsv 1+2 igm	W0105040304	Anti-HSV-1/2 IgM Abs.98/79	– 98/79	EUDAMED record Report an error
Hsv 2 igg	W0105040309	Anti-HSV-2 IgG98/79	– 98/79	EUDAMED record Report an error
Hsv 2 igm	W0105040310	Anti-HSV-2 IgM Abs.98/79	– 98/79	EUDAMED record Report an error
IVD general use consumable devices - other	W0599	Stool Extraction Medium F5126	A IVDR	EUDAMED record Report an error
Measles virus igg	W0105040702	Anti-Measles Virus IgG ORG 909G98/79	– 98/79	EUDAMED record Report an error
Measles virus igm	W0105040703	Anti-Measles Virus IgM Abs.98/79	– 98/79	EUDAMED record Report an error
Mumps / parotitis virus igg	W0105040802	Anti-Mumps Virus IgG ORG 908G98/79	– 98/79	EUDAMED record Report an error
Mumps / parotitis virus igm	W0105040803	Anti-Mumps Virus IgM Abs.98/79	– 98/79	EUDAMED record Report an error
Varicella zoster virus igg	W0105040902	Anti-VZV IgG ORG 914G98/79	– 98/79	EUDAMED record Report an error
Varicella zoster virus igm	W0105040903	Anti-VZV IgM Abs.98/79	– 98/79	EUDAMED record Report an error
Varicella zoster virus reagents - other	W0105040999	Anti-VZV IgA ORG 914A98/79	– 98/79	EUDAMED record Report an error

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