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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 3 of 9

Device	Model / Reference	Registries	Class	Status
EUROPLUS Granulocyte Mosaic 20	FA 1201-2010-20	FDA UDI	Class II	Unknown
Anti-Candida albicans IFA (IgM)	FI 2861-1003 M	FDA UDI	Class II	Unknown
Anti-SS-A ELISA (IgG)	EA 1595-9601 G	FDA UDI	Class II	Active
EUROPLUS Granulocyte Mosaic 25 EUROPattern	FC 1201-18010-25	FDA UDI	Class II	Unknown
Anti-Bordetella pertussis toxin ELISA (IgG)	EI 2050-9601 G	FDA UDI	Class I	Unknown
EUROPLUS Granulocyte Mosaic 22 EUROPattern	FC 1201-1050-22	FDA UDI	Class II	Unknown
Anti-RSV IFA (IgG)	FI 2670-1003 G	FDA UDI	Class I	Unknown
EUROPLUS Granulocyte Mosaic 25 EUROPattern	FC 1201-2005-25	FDA UDI	Class II	Active
EUROPLUS Granulocyte Mosaic 32	FA 1201-1005-32	FDA UDI	Class II	Active
IFA: Granulocyte Mosaic 2 EUROPattern	FC 1201-18010-2	FDA UDI	Class II	Unknown
Adjustment solution	ZE 1120-1050-6	FDA UDI	Class I	Unknown
Anti-Candida albicans IFA (IgG)	FI 2861-2005 G	FDA UDI	Class II	Unknown
IFA Mosaic: Coxsackie virus A Types (IgG)	FI 2730-2010-2 G	FDA UDI	Class I	Active
IFA 40: HEp-20-10	FA 1522-1010-1	FDA UDI	Class II	Active
Sprinter XL (model 240 samples, IFA incl. incubator)	YG 0033-0101-24	FDA UDI	Class I	Unknown
EUROPLUS Granulocyte Mosaic 22 EUROPattern	FC 1201-12010-22	FDA UDI	Class II	Unknown
Anti-Measles Virus ELISA (IgG)	EI 2610-9601 G	FDA UDI	Class I	Active
IFA: Oesophagus (Monkey) IgA EUROPattern	FC 1911-1005 A	FDA UDI	Class II	Active
Anti-Echinococcus granulosus IFA (IgG)	FI 2320-1003 G	FDA UDI	Class I	Unknown
EUROPLUS Granulocyte Mosaic 32 EUROPattern	FC 1201-2450-32	FDA UDI	Class II	Unknown
Anti-ENA Pool ELISA (IgG)	EA 1590-9601-9 G	FDA UDI	Class II	Active
Anti-Mycoplasma pneumoniae IFA (IgG)	FI 2202-1010 G	FDA UDI	Class I	Unknown
Anti-Adenovirus IFA (IgG)	FI 2680-1005 G	FDA UDI	Class I	Unknown
IF Sprinter (model IFA/ELISA)	YG 0032-0101-2	FDA UDI	Class I	Unknown
EUROLabLiquidHandler (30-10)	YG 0830-0101-10	FDA UDI	Class I	Unknown
EUROPLUS Granulocyte Mosaic 25 EUROPattern	FC 1201-2010-25	FDA UDI	Class II	Active
Mounting medium (IIFT)	ZF 1200-1003-R	FDA UDI	Class I	Active
EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)	DL 1300-6401-8 G	FDA UDI	Class II	Active
Pipettor Validation Test Kit	ZG 0410-0101	FDA UDI	Class I	Unknown
Anti-Adenovirus ELISA (IgM)	EI 2680-9601 M	FDA UDI	Class I	Unknown
IFA: Granulocyte Mosaic 13 EUROPattern	FC 1201-1005-13	FDA UDI	Class II	Active
EUROPLUS Granulocyte Mosaic 32 EUROPattern	FC 1201-2010-32	FDA UDI	Class II	Active
Anti-RSV IFA (IgG)	FI 2670-2010 G	FDA UDI	Class I	Unknown
Anti-Candida albicans IFA (IgA)	FI 2861-2010 A	FDA UDI	Class II	Unknown
Anti-PLA2R IFA	FA 1254-2010-50	FDA UDI	Class II	Active
IFA: Granulocyte Mosaic 13	FA 1201-2005-13	FDA UDI	Class II	Active
EUROPLUS Granulocyte Mosaic 32	FA 1201-1003-32	FDA UDI	Class II	Unknown
IFA: Legionella Mosaic 4 (IgG)	FI 2150-2005-4 G	FDA UDI	Class II	Unknown
Anti-Mycoplasma pneumoniae ELISA (IgM)	EI 2202-9601 M	FDA UDI	Class I	Unknown
IFA: Granulocyte Mosaic 13	FA 1201-1050-13	FDA UDI	Class II	Active
Anti-Adenovirus IFA (IgM)	FI 2680-1005 M	FDA UDI	Class I	Unknown
IFA Mosaic: Coxsackie virus (IgG)	FI 2730-1005-1 G	FDA UDI	Class I	Active
Anti-Brucella abortus ELISA (IgG)	EI 2189-9601 G	FDA UDI	Class II	Active
ANA IFA: HEp-20-10	FA 1522-2003	FDA UDI	Class II	Unknown
Anti-Candida albicans IFA (IgM)	FI 2861-2005 M	FDA UDI	Class II	Unknown
IFA: Granulocytes (EOH)	FA 1200-1005	FDA UDI	Class II	Active
Total Estrogens ELISA	EQ 6160-9601-1	FDA UDI	Class I	Active
IFA: Oesophagus (Monkey) IgA EUROPattern	FC 1911-1010 A	FDA UDI	Class II	Active
IFA: Oesophagus (Monkey) IgA EUROPattern	FC 1911-12010 A	FDA UDI	Class II	Active
EURORealTime SARS-CoV-2	MP 2606-0100	FDA UDI	N	Active

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FDA Establishments (1)

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