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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)

Page 6 of 9

Device	Model / Reference	Registries	Class	Status
EUROPLUS Granulocyte Mosaic 32 EUROPattern	FC 1201-1050-32	FDA UDI	Class II	Unknown
Sprinter XL (model 240 samples, IFA/ELISA incl. Incubator)	YG 0033-0101-23	FDA UDI	Class I	Unknown
IFA: Oesophagus (Monkey) IgA	FA 1911-2005 A	FDA UDI	Class II	Active
Anti-Sm ELISA (IgG)	EA 1593-9601 G	FDA UDI	Class II	Active
FITC-labelled anti-human IgG	AF 102-0546-R	FDA UDI	Class I	Active
EUROLINE ENA Profile 9 Ag (IgG)	DL 1590-1601-9 G	FDA UDI	Class II	Active
Anti-LKM-1 ELISA (IgG)	EA 1321-9601 G	FDA UDI	Class II	Active
EUROPLUS Granulocyte Mosaic 22 EUROPattern	FC 1201-18010-22	FDA UDI	Class II	Unknown
IFA: Granulocyte Mosaic 13	FA 1201-1010-13	FDA UDI	Class II	Active
EUROPLUS Granulocyte Mosaic 20	FA 1201-1010-20	FDA UDI	Class II	Unknown
Anti-Adenovirus IFA (IgG)	FI 2680-1003 G	FDA UDI	Class I	Unknown
IFA: Granulocyte Mosaic 2	FA 1201-2010-2	FDA UDI	Class II	Active
IFA: Crithidia luciliae (anti-dsDNA) EUROPattern	FC 1572-1010	FDA UDI	Class II	Active
Anti-Mycoplasma pneumoniae IFA (IgA)	FI 2202-1003 A	FDA UDI	Class I	Unknown
Anti-RSV IFA (IgM)	FI 2670-2005 M	FDA UDI	Class I	Unknown
Mounting medium (IIFT)	ZF 1200-0430-R	FDA UDI	Class I	Active
IFA: Granulocyte Mosaic 2	FA 1201-2003-2	FDA UDI	Class II	Unknown
Device Qualification Test Kit EUROLabWorkstation IFA	ZG 0866-0101-3	FDA UDI	Class I	Active
Lyme ELISA (IgG/IgM)	EI 2132-9601-24 O	FDA UDI	Class II	Active
IFA: Granulocyte Mosaic 2 EUROPattern	FC 1201-2005-2	FDA UDI	Class II	Active
Uniqo 160	YG 2900-0101-1	FDA UDI	Class I	Active
Sample buffer 2, Crithidia luciliae sensitive (IFA)	ZF 1020-0530-2-R	FDA UDI	Class I	Active
EURORealTime SARS-CoV-2	MP 2606-0225	FDA UDI	N	Active
Anti-Desmoglein 3 ELISA (IgG)	EA 1496-4801 G	FDA UDI	Class II	Active
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)	DY 2133-3001-1 M	FDA UDI	Class II	Active
Anti-Parainfluenza Viruses Pool ELISA (IgG)	EI 2721-9601-1 G	FDA UDI	Class I	Active
Anti-Measles virus IFA (IgG)	FI 2610-1003 G	FDA UDI	Class I	Unknown
IFA: Granulocyte Mosaic 13	FA 1201-1003-13	FDA UDI	Class II	Unknown
IFA: Granulocytes (HCHO)	FA 1201-1010	FDA UDI	Class II	Active
Anti-Mycoplasma pneumoniae IFA (IgA)	FI 2202-1005 A	FDA UDI	Class I	Unknown
Avidity: Anti-Measles Virus ELISA (IgG)	EI 2610-9601-1 G	FDA UDI	Class I	Unknown
Anti-Echinococcus granulosus IFA (IgG)	FI 2320-2005 G	FDA UDI	Class I	Unknown
EUROPLUS Granulocyte Mosaic 22 EUROPattern	FC 1201-1005-22	FDA UDI	Class II	Active
Anti-Measles Virus ELISA (IgM)	EI 2610-9601 M	FDA UDI	Class I	Unknown
IFA: Granulocytes (HCHO)	FA 1201-2005	FDA UDI	Class II	Unknown
IFA: BIOCHIP Sequence Legionella pneumophila (IgAGM)	FI 2150-2001 P	FDA UDI	Class II	Unknown
EUROPattern Microscope Live	YG 0371-0101	FDA UDI	Class I	Unknown
Anti-ß2-Glycoprotein 1 ELISA (IgA)	EA 1632-9601 A	FDA UDI	Class I	Unknown
EUROStar III Plus	YG 0306-0101-3	FDA UDI	Class I	Active
EUROArrayProcessor Pre-PCR Software	YG 0671-0101-2	FDA UDI	Class II	Active
EUROLINE Bordetella pertussis (IgG)	DN 2050-24001 G	FDA UDI	Class I	Active
Anti-Influenza A Virus ELISA (IgA)	EI 2691-9601 A	FDA UDI	Class I	Unknown
Total Testosterone ELISA	EQ 6151-9601-1	FDA UDI	Class I	Unknown
IFA Mosaic: Coxsackie virus Type A7 / Type B1 (IgG)	FI 2730-1010-4 G	FDA UDI	Class I	Active
Dehydroepiandrosterone (DHEA) ELISA	EQ 6154-9601-1	FDA UDI	Class I	Active
EUROPLUS Granulocyte Mosaic 22	FA 1201-1010-22	FDA UDI	Class II	Active
IFA: Legionella pneumophila Screening (Mix 1 / Mix 2) (IgAGM)	FI 215b-1010-1 P	FDA UDI	Class II	Unknown
Anti-Desmoglein 1 ELISA (IgG)	EA 1495-4801 G	FDA UDI	Class II	Active
EUROArrayScanner	YG 0602-0101	FDA UDI	Class II	Active
Anti-ß2-Glycoprotein 1 ELISA (IgAGM)	EA 1632-9601 P	FDA UDI	Class I	Unknown

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