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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 (422)

Page 1 of 9

Device	Model / Reference	Registries	Class	Status
IIFT: Flavivirus Mosaic 1 (IgM)	FI 2661-1010-1 M	EUDAMED	IVD General	Active
myfoodprofile advanced 1	NP 7124-1604-1 G	EUDAMED	IVD General	Active
IIFT: Anti-VGKC associated proteins Mosaic 1 EUROPattern	FC 1439-12010-1	EUDAMED	IVD General	Active
Anti-RSV IFA (IgG)	FI 2670-2005 G	FDA UDI	Class I	Unknown
Anti-Measles virus IFA (IgM)	FI 2610-1003 M	FDA UDI	Class I	Unknown
Anti-Mumps virus IFA (IgG)	FI 2630-2010 G	FDA UDI	Class I	Unknown
IFA Mosaic: Coxsackie virus B Types (IgG)	FI 2730-2005-3 G	FDA UDI	Class I	Active
IFA: Legionella pneumophila Screening (Mix 1) (IgAGM)	FI 215b-1003 P	FDA UDI	Class II	Unknown
Device Qualification Test Kit EUROLabLiquidHandler	ZG 0866-0101-1	FDA UDI	Class I	Active
Anti-Mycoplasma pneumoniae IFA (IgG)	FI 2202-2005 G	FDA UDI	Class I	Unknown
Anti-PLA2R IFA	FA 1254-1010-50	FDA UDI	Class II	Active
Anti-Glutamate receptor (type NMDA) IFA	FA 112d-1003-51	FDA UDI	Class II	Unknown
IFA: Granulocyte Mosaic 13	FB 1201-2010-13	FDA UDI	Class II	Active
Anti-Adenovirus IFA (IgG)	FI 2680-2005 G	FDA UDI	Class I	Unknown
EUROPLUS Granulocyte Mosaic 22 EUROPattern	FC 1201-2005-22	FDA UDI	Class II	Unknown
Anti-Mumps virus IFA (IgM)	FI 2630-1010 M	FDA UDI	Class I	Unknown
EUROPLUS Granulocyte Mosaic 32 EUROPattern	FC 1201-12010-32	FDA UDI	Class II	Active
IFA: Oesophagus (Monkey) IgA	FA 1911-1005 A	FDA UDI	Class II	Active
Anti-Candida albicans IFA (IgG)	FI 2861-1003 G	FDA UDI	Class II	Unknown
Anti-West Nile Virus ELISA (IgG)	EI 2662-9601 G	FDA UDI	Class II	Active
IFA: Legionella pneumophila Screening (Mix 1 / Mix 2) (IgAGM)	FI 215b-2005-1 P	FDA UDI	Class II	Unknown
EUROPLUS Granulocyte Mosaic 25 EUROPattern	FC 1201-1050-25	FDA UDI	Class II	Unknown
FITC-labelled anti-human IgG	AF 102-0540-R	FDA UDI	Class I	Active
Anti-Mumps Virus ELISA (IgG)	EI 2630-9601 G	FDA UDI	Class I	Active
Anti-Candida albicans IFA (IgA)	FI 2861-1005 A	FDA UDI	Class II	Unknown
Anti-PLA2R ELISA (IgG)	EA 1254-9601 G	FDA UDI	Class II	Active
IFA Mosaic: Legionella non-pneumophila (IgAGM)	FI 216f-1005-1 P	FDA UDI	Class II	Unknown
Anti-Mumps virus IFA (IgG)	FI 2630-2005 G	FDA UDI	Class I	Unknown
Anti-Mumps virus IFA (IgG)	FI 2630-1003 G	FDA UDI	Class I	Unknown
IFA: Granulocyte Mosaic 13 EUROPattern	FC 1201-2450-13	FDA UDI	Class II	Active
EUROArray wash buffer set	ZM 0123-0101-R	FDA UDI	Class I	Active
Anti-Candida albicans IFA (IgM)	FI 2861-1005 M	FDA UDI	Class II	Unknown
Anti-Mycoplasma pneumoniae ELISA (IgA)	EI 2202-9601 A	FDA UDI	Class I	Unknown
Anti-PR3-hn-hr ELISA (IgG)	EA 1201-9601-2 G	FDA UDI	Class II	Active
Anti-Echinococcus granulosus IFA (IgG)	FI 2320-1010 G	FDA UDI	Class I	Unknown
EUROPLUS Granulocyte Mosaic 32	FA 1201-2010-32	FDA UDI	Class II	Active
25-OH Vitamin D ELISA	EQ 6411-9601	FDA UDI	Class II	Active
Anti-Mycoplasma pneumoniae IFA (IgM)	FI 2202-1005 M	FDA UDI	Class I	Unknown
Anti-Candida albicans IFA (IgG)	FI 2861-1005 G	FDA UDI	Class II	Unknown
Anti-SARS-CoV-2 S1 Curve ELISA (IgG)	EI 2606-9601-20 G	FDA UDI	N	Unknown
Anti-SLA/LP ELISA (IgG)	EA 1302-9601 G	FDA UDI	Class II	Active
Anti-Jo-1 ELISA (IgG)	EA 1661-9601 G	FDA UDI	Class II	Active
System Qualification Test Kit	ZG 0865-0101	FDA UDI	Class I	Unknown
Anti-Mycoplasma pneumoniae IFA (IgM)	FI 2202-1010 M	FDA UDI	Class I	Unknown
Anti-Glutamate receptor (type NMDA) IFA	FA 112d-2010-51	FDA UDI	Class II	Unknown
IFA: Crithidia luciliae (anti-dsDNA) EUROPattern	FC 1572-2010	FDA UDI	Class II	Active
Anti-Schistosoma ELISA (IgG)	EI 2300-9601 G	FDA UDI	Class I	Active
Anti-RSV IFA (IgG)	FI 2670-1010 G	FDA UDI	Class I	Unknown
IFA: Legionella Mosaic 4 (IgAGM)	FI 2150-1005-4 P	FDA UDI	Class II	Unknown
IFA: Oesophagus (Monkey) IgA	FA 1911-1010 A	FDA UDI	Class II	Active

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