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EUROIMMUN Medizinische Labordiagnostika AG

Germany·DE-MF-000005296

Last updated September 17, 2026

Part of EUROIMMUN Medizinische Labordiagnostika AG

What EUROIMMUN Medizinische Labordiagnostika AG makes

EUROIMMUN Medizinische Labordiagnostika AG manufactures in vitro diagnostic (IVD) kits and reagents for detecting autoantibodies and viral antibodies using fluorescent immunoassay and enzyme immunoassay methods, including tests for ANCA, ANA, anti-dsDNA, EMA, Coxsackie virus, anti-PLA2R, anti-ENA, and related pathogens, along with associated software and buffer solutions.

The company's devices are classified as Class A, Class I, Class II, and N under regulatory frameworks and are listed in both EUDAMED and the FDA UDI database; the company is based in Germany.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does EUROIMMUN Medizinische Labordiagnostika AG manufacture?

Where is EUROIMMUN Medizinische Labordiagnostika AG based?

EUROIMMUN Medizinische Labordiagnostika AG is based in Germany, as indicated by the country code DE in the provided data.

Which regulatory registries list the devices of EUROIMMUN Medizinische Labordiagnostika AG?

The devices of EUROIMMUN Medizinische Labordiagnostika AG are listed in both EUDAMED and the FDA UDI database, as explicitly stated in the LISTED IN field of the provided data.

How are the devices of EUROIMMUN Medizinische Labordiagnostika AG classified?

The devices of EUROIMMUN Medizinische Labordiagnostika AG are classified as Class A, Class I, Class II, and N under applicable regulatory frameworks, as specified in the DEVICE CLASSES field of the provided data.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: Germany
Address: 31, Seekamp , Lübeck, Germany
Website: www.euroimmun.de
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +49 451 2032-0
PRRC Contact: Arne Weidmann
EUDAMED SRN: DE-MF-000005296
FDA FEI Number: 3007361513
DUNS Number: 322209263

Catalogue (430)

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Device	Model / Reference	Registries	Class	Status
Anti-Legionella pneumophila ELISA (IgM)	EI 2150-9601 M	FDA UDI	Class II	Unknown
Dehydroepiandrosterone Sulfate (DHEA-S) ELISA	EQ 6155-9601	FDA UDI	Class I	Unknown
Anti-Adenovirus ELISA (IgA)	EI 2680-9601 A	FDA UDI	Class I	Unknown
Anti-Strongyloides ELISA (IgG)	EI 2290-9601 G	FDA UDI	Class I	Active
IFA: Crithidia luciliae (anti-dsDNA) EUROPattern	FC 1572-1005	FDA UDI	Class II	Active
Anti-West Nile Virus ELISA (IgM)	EI 2662-9601 M	FDA UDI	Class II	Active
Legionella pneumophila Screening (Mix 1/2/3/4) IFA (IgAGM)	FI 2150-2005-3 P	FDA UDI	Class II	Unknown
Anti-RSV ELISA (IgA)	EI 2670-9601 A	FDA UDI	Class I	Unknown
EUROPLUS Granulocyte Mosaic 22 EUROPattern	FC 1201-2450-22	FDA UDI	Class II	Unknown
Anti-Mumps virus IFA (IgM)	FI 2630-2005 M	FDA UDI	Class I	Unknown
Anti-ß2-Glycoprotein 1 ELISA (IgG)	EA 1632-9601 G	FDA UDI	Class I	Unknown
IFA: Granulocyte Mosaic 2 EUROPattern	FC 1201-2010-2	FDA UDI	Class II	Active
Anti-tissue Transglutaminase ELISA (IgG)	EA 1910-9601 G	FDA UDI	Class II	Active
IFA: Granulocyte Mosaic 13	FA 1201-2010-13	FDA UDI	Class II	Active
IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern	FC 1572-1010-1	FDA UDI	Class II	Active
EUROPLUS Granulocyte Mosaic 22	FA 1201-1005-22	FDA UDI	Class II	Active
Anti-Echinococcus EUROLINE WB (IgG)	DY 2321-1601-1 G	FDA UDI	Class I	Active
Anti-Borrelia burgdorferi US WESTERNBLOT (IgG)	DY 2133-3001 G	FDA UDI	Class II	Active
EUROPLUS Granulocyte Mosaic 32 EUROPattern	FC 1201-18010-32	FDA UDI	Class II	Unknown
EUROLineScan	YG 0006-0101	FDA UDI	Class I	Active
EUROLINE ENA Profile 9 Ag (IgG)	DL 1590-6401-9 G	FDA UDI	Class II	Active
Anti-Echinococcus ELISA (IgG)	EI 2320-9601-1 G	FDA UDI	Class I	Active
IFA: Oesophagus (Monkey) IgA EUROPattern	FC 1911-2005 A	FDA UDI	Class II	Active
Anti-dsDNA-NcX ELISA (IgG)	EA 1572-9601 G	FDA UDI	Class II	Active
IFA: Oesophagus (Monkey) IgA	FA 1911-1003 A	FDA UDI	Class II	Unknown
Anti-Mycoplasma pneumoniae IFA (IgA)	FI 2202-2005 A	FDA UDI	Class I	Unknown
Anti-Mumps virus IFA (IgG)	FI 2630-1010 G	FDA UDI	Class I	Unknown
ELISA Stop solution	ZE 1210-1012	FDA UDI	Class I	Active
IFA: Granulocyte Mosaic 13 EUROPattern	FC 1201-1050-13	FDA UDI	Class II	Unknown
IFA: Granulocyte Mosaic 13 EUROPattern	FC 1201-1010-13	FDA UDI	Class II	Active
EUROPLUS Granulocyte Mosaic 22	FA 1201-1003-22	FDA UDI	Class II	Unknown
Anti-Candida albicans IFA (IgG)	FI 2861-1010 G	FDA UDI	Class II	Unknown
EUROPLUS Granulocyte Mosaic 22 EUROPattern	FC 1201-2010-22	FDA UDI	Class II	Active
EUROArrayProcessor	YG 0671-0101-1	FDA UDI	Class II	Active
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)	DY 2133-24001-1 M	FDA UDI	Class II	Active
Anti-tissue Transglutaminase ELISA (IgA)	EA 1910-9601 A	FDA UDI	Class II	Active
Anti-Mumps virus IFA (IgM)	FI 2630-1003 M	FDA UDI	Class I	Unknown
Secondary reagents immunoblot (IgM)	ZD 1129-0101-1 M	FDA UDI	Class I	Active
Pregnenolone ELISA	EQ 6164-9601	FDA UDI	Class I	Active
IFA: Granulocyte Mosaic 2 EUROPattern	FC 1201-1050-2	FDA UDI	Class II	Unknown
EURORealTime SARS-CoV-2	MP 2606-0425	FDA UDI	N	Active
EUROPLUS Granulocyte Mosaic 32	FA 1201-2005-32	FDA UDI	Class II	Active
Anti-Echinococcus granulosus IFA (IgG)	FI 2320-1005 G	FDA UDI	Class I	Unknown
Sample buffer (IFA)	ZF 1020-0545-R	FDA UDI	Class I	Active
Adjustment solution	ZE 1120-1850-7	FDA UDI	Class I	Active
EUROPicture	YG 0011-0101	FDA UDI	Class I	Active
IFA: Granulocyte Mosaic 4	FA 1201-1010-4	FDA UDI	Class II	Unknown
IFA 40: HEp-20-10 EUROPattern	FC 1522-2005-1	FDA UDI	Class II	Unknown
EUROLabLiquidHandler (30-08)	YG 0830-0101-8	FDA UDI	Class I	Unknown
Anti-PLA2R IFA	FA 1254-1003-50	FDA UDI	Class II	Unknown

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EUROIMMUN Medizinische Labordiagnostika AG Dassow Mecklenburg-Western Pomerania · DE FEI 3007361513