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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-RSV ELISA (IgG)	EI 2670-9601 G	FDA UDI	Class I	Active
EUROPLUS Granulocyte Mosaic 22 EUROPattern	FC 1201-1010-22	FDA UDI	Class II	Active
IFA: Oesophagus (Monkey) IgA EUROPattern	FC 1911-0010 A	FDA UDI	Class II	Unknown
Anti-Mycoplasma pneumoniae IFA (IgA)	FI 2202-1010 A	FDA UDI	Class I	Unknown
EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)	DL 1300-1601-8 G	FDA UDI	Class II	Active
Anti-RSV ELISA (IgM)	EI 2670-9601 M	FDA UDI	Class I	Unknown
Anti-ribosomal P Proteins ELISA (IgG)	EA 1641-9601 G	FDA UDI	Class II	Active
ANA IFA: HEp-20-10	FA 1522-2005	FDA UDI	N/A	Active
IFA: Granulocyte Mosaic 2 EUROPattern	FC 1201-2450-2	FDA UDI	Class II	Unknown
IFA 40: HEp-20-10 EUROPattern	FC 1522-1050-1	FDA UDI	Class II	Unknown
IFA: BIOCHIP Sequence Legionella pneumophila (IgAGM)	FI 2150-2002 P	FDA UDI	Class II	Unknown
Anti-Mycoplasma pneumoniae IFA (IgM)	FI 2202-2005 M	FDA UDI	Class I	Unknown
Sprinter XL (model 160 samples, IFA/ELISA)	YG 0033-0101-6	FDA UDI	Class I	Unknown
IFA 40: HEp-20-10 EUROPattern	FC 1522-2010-1	FDA UDI	Class II	Active
EUROPLUS Granulocyte Mosaic 32	FA 1201-1010-32	FDA UDI	Class II	Active
Legionella pneumophila Screening (Mix 1/2/3/4) IFA (IgAGM)	FI 2150-1005-3 P	FDA UDI	Class II	Unknown
IFA: Granulocyte Mosaic 2	FA 1201-1003-2	FDA UDI	Class II	Unknown
Secondary reagents immunoblot (IgG)	ZD 1129-0101-1 G	FDA UDI	Class I	Active
IFA: Legionella pneumophila Screening (Mix 1 / Mix 2) (IgAGM)	FI 215b-1005-1 P	FDA UDI	Class II	Unknown
Anti-Influenza B Virus ELISA (IgA)	EI 2692-9601 A	FDA UDI	Class I	Unknown
EUROLabWorkstation ELISA	YG 0851-0101	FDA UDI	Class I	Active
Pbs (ifa)	ZF 1100-0410-R	FDA UDI	Class I	Active
Anti-Bordetella pertussis toxin ELISA (IgA)	EI 2050-9601 A	FDA UDI	Class I	Unknown
IFA: Granulocyte Mosaic 2 EUROPattern	FC 1201-12010-2	FDA UDI	Class II	Active
IFA: Granulocyte Mosaic 13 EUROPattern	FC 1201-2005-13	FDA UDI	Class II	Active
System liquid concentrate	ZG 0862-10100	FDA UDI	Class I	Active
ANA IFA: HEp-20-10	FA 1522-2010	FDA UDI	Class II	Active
IFA: Granulocyte Mosaic 2	FA 1201-1010-2	FDA UDI	Class II	Active
Sprinter XL	YG 0033-0101	FDA UDI	Class I	Active
EUROBlotOne	YG 0153-0101	FDA UDI	Class I	Active
Anti-BP230-CF ELISA (IgG)	EA 1502-4801-1 G	FDA UDI	Class II	Active
Anti-Adenovirus IFA (IgM)	FI 2680-1010 M	FDA UDI	Class I	Unknown
IFA: Granulocyte Mosaic 2	FA 1201-2005-2	FDA UDI	Class II	Active
IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern	FC 1572-2450-1	FDA UDI	Class II	Active
Free Testosterone ELISA	EQ 6151-9601	FDA UDI	Class I	Active
Anti-M2-3E ELISA (IgG)	EA 1622-9601 G	FDA UDI	Class II	Active
Free Triiodothyronine (FT3) ELISA	EQ 1016-9601	FDA UDI	Class II	Unknown
IFA: Crithidia luciliae (anti-dsDNA) EUROPattern	FC 1572-2005	FDA UDI	Class II	Active
Anti-Influenza B Virus ELISA (IgG)	EI 2692-9601 G	FDA UDI	Class I	Active
Anti-Legionella pneumophila ELISA (IgA)	EI 2150-9601 A	FDA UDI	Class II	Unknown
Anti-Measles Virus NP ELISA (IgM)	EI 2610-9601-4 M	FDA UDI	Class I	Unknown
Anti-Scl-70 ELISA (IgG)	EA 1599-9601 G	FDA UDI	Class II	Active
17-OH Progesterone ELISA	EQ 6163-9601	FDA UDI	Class I	Active
Anti-Adenovirus IFA (IgM)	FI 2680-2005 M	FDA UDI	Class I	Unknown
Anti-Gliadin (GAF-3X) ELISA (IgG)	EV 3011-9601 G	FDA UDI	Class II	Active
IFA: Legionella Mosaic 4 (IgG)	FI 2150-1010-4 G	FDA UDI	Class II	Unknown
EUROBlotMaster 44	YG 0151-0101-1	FDA UDI	Class I	Active
Anti-MPO ELISA (IgG)	EA 1211-9601 G	FDA UDI	Class II	Active
ANA IFA: HEp-20-10	FA 1522-1005	FDA UDI	Class II	Active
Anti-Legionella pneumophila ELISA (IgM)	EI 2150-9601 M	FDA UDI	Class II	Unknown

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FDA Establishments (1)

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