Manufacturer

Euroimmun

GermanyLegal entities : EUROIMMUN Medizinische Labordiagnostika AG

First countries of placing on the market declared in EUDAMED : Germany

Public contracts won : France 12, Italy 6, Poland 3, Denmark 1, Germany 1, Norway 1

102 categories, 448 models including 448 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Devices for samples analyses - other accessories	W05039080	Biotin-labelled anti-human IgG AF 402-1-R Coded glass plate for the incubation of slides with 10 fields ZZ 9999-15-R Coded glass plate for the incubation of slides with 50 fields ZZ 9999-16-R Coded reagent tray for slides with 10 fields ZZ 9999-12-R Coded reagent tray for slides with 5 fields ZZ 9999-11-R 29 others Coded reagent tray for slides with 50 fields ZZ 9999-13-R EUROArray wash buffer set ZM 0123-R EUROSORB (IIFT) ZF 1270-R FITC-labelled anti-human C3c with Evans Blue AF 612-R FITC-labelled anti-human IgA with Evans Blue AF 601-R FITC-labelled anti-human IgAGM AF 106-R2 refs FITC-labelled anti-human IgG (primate absorbed) AF 302-R2 refs FITC-labelled anti-human IgG AF 102-R2 refs FITC-labelled anti-human IgG with Evans Blue AF 602-R2 refs FITC-labelled anti-human IgG with propidium iodide for EUROPattern AF 702-2-R2 refs FITC-labelled anti-human IgG+IgG4 AF 104-R FITC-labelled anti-human IgM AF 103-R2 refs FITC-labelled anti-human IgM with Evans Blue AF 603-R FITC-labelled anti-human IgM with propidium iodide for EUROPattern AF 703-R FITC-labelled Avidin (biotin affine) AF 402-2-R Glycine urea buffer (IIFT) ZF 1140-R Human serum as complement source (IIFT) ZF 9000-R Mounting medium (IIFT) ZF 1200-R3 refs PBS (IIFT) ZF 1100-R2 refs PBS-Tween (IIFT) ZF 1101-R Reagent tray for incubation of slides ZZ 9999-R2 refs Reagent tray for the incubation of slides with 2 to 4 BIOCHIPs per field ZZ 9999-2-R Sample buffer (IIFT) ZF 1020-R3 refs Sample buffer 2, Crithidia luciliae sensitive (IIFT) ZF 1020-2-R2 refs TITERPLANE set for the incubation of slides with 10 fields ZZ 9999-18-R TITERPLANE set for the incubation of slides with 50 fields ZZ 9999-19-R Tween 20 (IIFT) ZF 1110-R2 refs WASH REAGENT 1 ZM 0121-R WASH REAGENT 2 ZM 0122-R	A IVDR	EUDAMED record Report an error
Viral antigen/antibody detection - other	W0105040699	Anti-Japanese encephalitis virus IIFT (IgG) FI 2663 G3 refs98/79 Anti-Japanese encephalitis virus IIFT (IgM) FI 2663 M2 refs98/79 Anti-JEV ELISA (IgG) EI 2663 G98/79 Anti-JEV ELISA (IgM) EI 2663 M98/79 Anti-Mayaro Virus ELISA (IgG) EI 295c G98/79 24 others Anti-Mayaro Virus ELISA (IgM) EI 295c M98/79 Anti-Oropouche Virus ELISA (IgG) EI 2771 G Anti-Oropouche Virus ELISA (IgM) EI 2771 M Anti-Toscana virus ELISA (IgG) EI 277c G98/79 Anti-Usutu Virus ELISA (IgG) EI 2667 G98/79 Anti-Yellow fever virus IIFT (IgG) FI 2665 G3 refs98/79 Anti-Yellow fever virus IIFT (IgM) FI 2665 M2 refs98/79 Anti-Yellow fever virus IIFT EUROPattern (IgG) FR 2665 G98/79 Anti-Yellow fever virus IIFT EUROPattern (IgM) FR 2665 M98/79 Arbovirus Fever Mosaic 2 IIFT (IgG) FI 2668-1-R G2 refs Arbovirus Fever Mosaic 2 IIFT (IgM) FI 2668-1-R M2 refs IIFT: Arbovirus Fever Mosaic 1 (IgG) FI 293a-1 G2 refs98/79 IIFT: Arbovirus Fever Mosaic 1 (IgM) FI 293a-1 M2 refs98/79 IIFT: Arbovirus Fever Mosaic 2 (IgG) FI 2668-1 G2 refs98/79 IIFT: Arbovirus Fever Mosaic 2 (IgM) FI 2668-1 M2 refs98/79 IIFT: Arbovirus Fever Mosaic 2 EUROPattern (IgG) FR 2668-1 G2 refs98/79 IIFT: Arbovirus Fever Mosaic 2 EUROPattern (IgM) FR 2668-1 M2 refs98/79 IIFT: Arbovirus Profile 3 (IgG) FI 2668-3 G98/79 IIFT: Arbovirus Profile 3 (IgM) FI 2668-3 M98/79 IIFT: Flavivirus Mosaic 1 (IgG) FI 2661-1 G2 refs98/79 IIFT: Flavivirus Mosaic 1 (IgM) FI 2661-1 M2 refs98/79 IIFT: Flavivirus Profile 2 (IgG) FI 2661-2 G2 refs98/79 IIFT: Flavivirus Profile 2 (IgM) FI 2661-2 M2 refs98/79 IIFT: TBEV-JEV Mosaic (IgG) FI 2661-4 G98/79	C IVDR, 98/79	EUDAMED record Report an error
Bacteriology controls - inf.imm.	W0105080801	Control set Anti-Borrelia ChLIA (IgG) LR 2132 G98/79 Control set Anti-Borrelia ChLIA (IgM) LR 2132 M98/79 CSQ pair of controls Anti-Borrelia (IgG) CK 2132-L G98/79 CSQ pair of controls Anti-Toxoplasma gondii (IgG) CK 2410-L G98/79 CSQ pair of controls Anti-Treponema pallidum (IgG) CK 2111-L G98/79 20 others Pos. control: anti-Borrelia afzelii (IgG), 50x concentrate CW 2131 G98/79 Pos. control: anti-Borrelia afzelii (IgM), 50x concentrate CW 2131 M98/79 Pos. control: anti-Borrelia burgdorferi (IgG), 50x concentrate CW 2132 G98/79 Pos. control: anti-Borrelia burgdorferi (IgM), 50x concentrate CW 2132 M98/79 Pos. control: anti-Borrelia garinii (IgG), 50x concentrate CW 2134 G98/79 Pos. control: anti-Borrelia garinii (IgM), 50x concentrate CW 2134 M98/79 Pos. control: anti-Helicobacter pylori (IgA), 50x concentrated CW 2080 A98/79 Pos. control: anti-Helicobacter pylori (IgG), 50x concentrated CW 2080 G98/79 Pos. control: anti-Yersinia enterocolitica (IgA), 50x concentrate CW 2173 A98/79 Pos. control: anti-Yersinia enterocolitica (IgG), 50x concentrate CW 2173 G98/79 Positive control (IgA, human), 50x concentrated CL 2050 A98/79 Positive control (IgA, human), 50x concentrated CL 2173 A98/79 Positive control (IgG, human), 50x concentrated CL 2050 G98/79 Positive control (IgG, human), 50x concentrated CL 2111 G98/79 Positive control (IgG, human), 50x concentrated CL 2131 G98/79 Positive control (IgG, human), 50x concentrated CL 2173 G98/79 Positive control (IgM, human), 50x concentrated CL 2111 M98/79 Positive control (IgM, human), 50x concentrated CL 2131 M98/79 Positive control: anti-Treponema pallidum (IgG), 50x concentrate CW 2111 G98/79 Positive control: anti-Treponema pallidum (IgM), 50x concentrate CW 2111 M98/79	– 98/79	EUDAMED record Report an error
Hantavirus / bunyavirus	W0105040614	Anti-Hanta Virus Pool 1 "Eurasia" ELISA (IgG) EI 278h-1 G98/79 Anti-Hanta Virus Pool 1 "Eurasia" ELISA (IgM) EI 278h-1 M98/79 Anti-Hanta Virus Pool 2 "America" ELISA (IgG) EI 278h-2 G98/79 Anti-Hanta Virus Pool 2 "America" ELISA (IgM) EI 278h-2 M98/79 IIFT: Hantavirus Mosaic 1 (IgG) FI 278h-1 G2 refs98/79 13 others IIFT: Hantavirus Mosaic 1 (IgM) FI 278h-1 M2 refs98/79 IIFT: Hantavirus Mosaic 1 EUROPattern (IgG) FR 278h-1 G98/79 IIFT: Hantavirus Mosaic 1 EUROPattern (IgM) FR 278h-1 M98/79 IIFT: Hantavirus Mosaic 2: Eurasia (IgG) FI 278h-2 G2 refs98/79 IIFT: Hantavirus Mosaic 2: Eurasia (IgM) FI 278h-2 M2 refs98/79 IIFT: Hantavirus Mosaic 3: America (IgG) FI 278m-3 G98/79 IIFT: Hantavirus Mosaic 3: America (IgM) FI 278m-3 M98/79 IIFT: Hantavirus Mosaic 3: America EUROPattern (IgG) FR 278m-3 G98/79 IIFT: Hantavirus Mosaic 3: America EUROPattern (IgM) FR 278m-3 M98/79 IIFT: Sandfly fever virus Mosaic 1 (IgG) FI 277a-1 G3 refs98/79 IIFT: Sandfly fever virus Mosaic 1 (IgM) FI 277a-1 M2 refs98/79 IIFT: Sandfly fever virus Mosaic 1 EUROPattern (IgG) FR 277a-1 G98/79 IIFT: Sandfly fever virus Mosaic 1 EUROPattern (IgM) FR 277a-1 M98/79	– 98/79	EUDAMED record Report an error
Other virology controls - inf.imm.	W0105080804	Control set Anti-EBNA-1 ChLIA (IgG) LR 2793 G98/79 Control set Anti-EBV-CA ChLIA (IgG) LR 2791 G98/79 Control set Anti-EBV-CA ChLIA (IgM) LR 2791 M98/79 Control set Anti-HSV 1 ChLIA (IgG) LR 2531 G98/79 Control set Anti-HSV 2 ChLIA (IgG) LR 2532 G98/79 13 others Control set Anti-SARS-CoV-2 RBD ChLIA (IgG) LR 2606-1 G98/79 CSQ pair of controls Anti-CMV (IgG) CK 2570-L G98/79 CSQ pair of controls Anti-EBV-CA (IgG) CK 2791-L G98/79 CSQ pair of controls Anti-HSV-1/2 Pool (IgG) CK 2531-1 L G98/79 CSQ pair of controls Anti-Measles virus (IgG) CK 2610-L G98/79 CSQ pair of controls Anti-Mumps virus (IgG) CK 2630-L G98/79 CSQ pair of controls Anti-Rubella virus (IgG) CK 2590-L G98/79 CSQ pair of controls Anti-VZV (IgG) CK 2650-L G98/79 Pos. control: anti-Herpes-simplex-virus (HSV) (IgG), 50x concentrate CW 2531 G98/79 Positive control (IgG, human), 50x concentrated CL 2570 G98/79 Positive control (IgG, human), 50x concentrated CL 2790-12 G98/79 Positive control (IgM, human), 50x concentrated CL 2570 M98/79 Positive control (IgM, human), 50x concentrated CL 2790-12 M98/79	– 98/79	EUDAMED record Report an error
Enterovirus	W0105040602	Anti-Enterovirus ELISA (IgA) EI 2730-1 A98/79 Anti-Enterovirus ELISA (IgG) EI 2730-1 G98/79 Anti-Enterovirus ELISA (IgM) EI 2730-1 M98/79 IIFT Mosaic: Coxsackie virus A Types (IgG) FI 2730-2 G3 refs98/79 IIFT Mosaic: Coxsackie virus A Types (IgM) FI 2730-2 M3 refs98/79 11 others IIFT: Coxsackie Virus Screen (types A) EUROPattern (IgG) FR 2730-2 G98/79 IIFT: Coxsackie Virus Screen (types A) EUROPattern (IgM) FR 2730-2 M98/79 IIFT: Coxsackie Virus Screen (types B) EUROPattern (IgG) FR 2730-3 G98/79 IIFT: Coxsackie Virus Screen (types B) EUROPattern (IgM) FR 2730-3 M98/79 Mosaic: Coxsackie virus (IgG) FI 2730-1 G98/79 Mosaic: Coxsackie virus (IgM) FI 2730-1 M98/79 Mosaic: Coxsackie virus B Types (IgG) FI 2730-3 G98/79 Mosaic: Coxsackie virus B Types (IgM) FI 2730-3 M2 refs98/79 Mosaic: Coxsackie virus B Types FI 2730-3 G98/79 Mosaic: Coxsackie virus Type A7 / Type B1 (IgA) FI 2730-4 A2 refs98/79 Mosaic: Coxsackie virus Type A7 / Type B1 FI 2730-4 G2 refs98/79	– 98/79	EUDAMED record Report an error
Lyme antibody igm	W0105010604	Anti-Borrelia afzelii-WESTERNBLOT (IgM) DY 2131 M2 refs98/79 Anti-Borrelia burgdorferi-WESTERNBLOT (IgM) DY 2132 M2 refs98/79 Anti-Borrelia ChLIA (IgM) LI 2132 M98/79 Anti-Borrelia CSF ELISA 2.0 (IgM) EI 2132-2L M Anti-Borrelia ELISA (IgM) EI 2132 M98/79 8 others Anti-Borrelia EUROLINE-RN-AT (IgM) DN 2131 M3 refs98/79 Anti-Borrelia EUROLINE-RN-AT-11 (IgM) DN 2131-11 M2 refs98/79 Anti-Borrelia EUROLINE-RN-AT-adv (IgM) DN 2131-2 M3 refs98/79 Anti-Borrelia EUROLINE-WB (IgM) DY 2131-1 M4 refs98/79 Anti-Borrelia garinii-WESTERNBLOT (IgM) DY 2134 M2 refs98/79 Anti-Borrelia Select ELISA (IgM) EI 2132-5 M98/79 EUROMicroblot Anti-Borrelia (IgM) KN 2131 M98/79 IIFT: Borrelia afzelii / VlsE / Borrelia burgdorferi / OspC (IgM) FI 2136-1 M2 refs98/79	B IVDR, 98/79	EUDAMED record Report an error
IVD general use consumables devices - other accessories	W0580	Device Qualification Test Kit EUROIMMUN Analyzer I / I-2P ZG 0866-4 Device Qualification Test Kit EUROLabLiquidHandler ZG 0866-1 Device Qualification Test Kit EUROLabWorkstation ELISA ZG 0866-2 Device Qualification Test Kit EUROLabWorkstation IFA ZG 0866-3 EUROArrayProcessor Reagent tray set ZM 9999-5 6 others Incubation plate set for UNIQO 400 ZZ 9999-26-R Incubation tray 30 channels (black) ZD 9895-1 Incubation tray 44 channels, black ZD 9892 Incubation tray, volume-reduced (10 channels, black) ZD 9897-13 refs Stool Dosage Tubes, ready for use ZE 6010-2 Stool Dosage Tubes, unfilled ZE 6010-3	A IVDR	EUDAMED record Report an error
Lyme antibody igg	W0105010603	Anti-Borrelia afzelii-WESTERNBLOT (IgG) DY 2131 G2 refs98/79 Anti-Borrelia ChLIA (IgG) LI 2132 G98/79 Anti-Borrelia EUROLINE-RN-AT (IgG) DN 2131 G3 refs98/79 Anti-Borrelia EUROLINE-RN-AT-11 (IgG) DN 2131-11 G2 refs98/79 Anti-Borrelia EUROLINE-WB (IgG) DY 2131-1 G4 refs98/79 6 others Anti-Borrelia garinii-WESTERNBLOT (IgG) DY 2134 G2 refs98/79 Anti-Borrelia plus VlsE ELISA (IgG) EI 2132-2 G98/79 Anti-Borrelia Select ELISA (IgG) EI 2132-5 G98/79 CSF: Anti-Borrelia plus VlsE ELISA (IgG) EI 2132-L G98/79 EUROMicroblot Anti-Borrelia (IgG) KN 2131 G98/79 IIFT: Borrelia afzelii / VlsE / Borrelia burgdorferi / OspC (IgG) FI 2136-1 G3 refs98/79	– 98/79	EUDAMED record Report an error
Dengue virus	W0105040611	Anti-Dengue Virus ELISA (IgG) EI 266b G98/79 Anti-Dengue Virus ELISA (IgM) EI 266b M98/79 Anti-Dengue Virus NS1 ELISA 2.0 (IgG) EI 266a-3 G Anti-Dengue Virus Type 1-4 ELISA (IgG) EI 266a-1 G98/79 Anti-Dengue Virus Type 1-4 ELISA (IgM) EI 266a-1 M98/79 5 others Dengue Virus NS1 ELISA EQ 266a-198/79 Mosaic: Dengue virus types 1-4 IIFT (IgG) FI 266a-1 G3 refs98/79 Mosaic: Dengue virus types 1-4 IIFT (IgM) FI 266a-1 M3 refs98/79 Mosaic: Dengue virus types 1-4 IIFT EUROPattern (IgG) FR 266a-1 G2 refs98/79 Mosaic: Dengue virus types 1-4 IIFT EUROPattern (IgM) FR 266a-1 M2 refs98/79	B IVDR, 98/79	EUDAMED record Report an error
Ebv antibodies - other	W010504040199	Anti-EBV-CA ELISA (IgA) EI 2791 A98/79 Anti-EBV-EA-D ELISA (IgA) EI 2795 A98/79 BIOCHIP Sequence EBV (Avidity determination) FI 2799-1 X4 refs98/79 EUROLINE Anti-EBV (IgG) DN 2790-4 G3 refs EUROLINE Anti-EBV (IgM) DN 2790-4 M3 refs 5 others EUROLINE Anti-EBV Profile 2 (IgG) DN 2790-2 G3 refs98/79 EUROLINE Anti-EBV Profile 2 (IgM) DN 2790-2 M3 refs98/79 EUROMicroblot Anti-EBV (IgG) KN 2790 G EUROMicroblot Anti-EBV (IgM) KN 2790 M EUROPLUS BIOCHIP Sequence EBV plus gp125 / p19 FI 2799-21 X4 refs98/79	B IVDR, 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	EUROBlotMaster 44 YG 0151-1 EUROBlotMaster YG 0151 EUROBlotOne YG 0153 EUROIMMUN Analyzer I YG 0014 EUROIMMUN Analyzer I-2P YG 0015 4 others IF Sprinter YG 0032 Sprinter XL YG 0033 UNIQO 160 YG 2900 UNIQO 400 YG 0400	A IVDR	EUDAMED record Report an error
Bordetella pertussis / parapertussis	W0105011707	Anti-Bordetella FHA ELISA (IgA) EI 2050-3 A98/79 Anti-Bordetella FHA ELISA (IgG) EI 2050-3 G98/79 Anti-Bordetella pertussis ELISA (IgM) EI 2050 M98/79 Anti-Bordetella pertussis toxin ELISA (IgA) EI 2050 A98/79 Anti-Bordetella pertussis toxin ELISA (IgG) EI 2050 G98/79 2 others EUROLINE Bordetella pertussis (IgA) DN 2050 A2 refs98/79 EUROLINE Bordetella pertussis (IgG) DN 2050 G2 refs98/79	– 98/79	EUDAMED record Report an error
Syphilis antibody igg	W0105010303	Anti-Treponema pallidum ELISA (IgG) EI 2111 G98/79 Anti-Treponema pallidum IIFT (IgG) FI 2111 G4 refs98/79 Anti-Treponema pallidum WESTERNBLOT (IgG) DY 2111 G2 refs98/79 CSF: Anti-Treponema pallidum ELISA (IgG) EI 2111-L G98/79 DY 2112 G - EWR - IVDD - Klasse Sonstige IVD2 refs98/79 2 others EUROLINE Anti-Treponema pallidum (IgG) DN 2111 G2 refs98/79 IIFT Mosaic: Treponema pallidum / Treponema phagedenis (IgG) FI 2112 G2 refs98/79	– 98/79	EUDAMED record Report an error
Zika virus	W0105040630	Anti-Zika Virus ELISA (IgAM) EI 2668 Q98/79 Anti-Zika Virus ELISA (IgG) EI 2668 G98/79 Anti-Zika Virus ELISA (IgM) EI 2668 M98/79 Anti-Zika virus IIFT (IgG) FI 2668 G2 refs98/79 Anti-Zika virus IIFT (IgM) FI 2668 M2 refs98/79 2 others Anti-Zika virus IIFT EUROPattern (IgG) FR 2668 G2 refs98/79 Anti-Zika virus IIFT EUROPattern (IgM) FR 2668 M2 refs98/79	– 98/79	EUDAMED record Report an error
Bacteriology immunoassay - other	W0105011799	Anti-Bartonella henselae IIFT (IgG) FI 219b G2 refs98/79 Anti-Bartonella henselae IIFT (IgM) FI 219b M2 refs98/79 IIFT Mosaic: Bartonella henselae / Bartonella quintana EUROPattern (IgG) FR 219b-1 G2 refs98/79 IIFT: Bartonella henselae / Bartonella quintana (IgG) FI 219b-1 G2 refs98/79 IIFT: Bartonella henselae / Bartonella quintana (IgM) FI 219b-1 M3 refs98/79 1 other IIFT: Bartonella henselae / Bartonella quintana EUROPattern (IgM) FR 219b-1 M2 refs98/79	– 98/79	EUDAMED record Report an error
Chikungunya virus	W0105040625	Anti-Chikungunya Virus ELISA (IgG) EI 293a G98/79 Anti-Chikungunya Virus ELISA (IgM) EI 293a M98/79 Anti-Chikungunya virus IIFT (IgG) FI 293a G3 refs98/79 Anti-Chikungunya virus IIFT (IgM) FI 293a M3 refs98/79 Anti-Chikungunya virus IIFT EUROPattern (IgG) FR 293a G2 refs98/79 1 other Anti-Chikungunya virus IIFT EUROPattern (IgM) FR 293a M2 refs98/79	– 98/79	EUDAMED record Report an error
Chlamydia reagents - other	W0105010199	Anti-Chlamydia MIF (IgA) FI 2191-3 A3 refs98/79 Anti-Chlamydia MIF (IgG) FI 2191-3 G3 refs98/79 Anti-Chlamydia MIF (IgM) FI 2191-3 M3 refs98/79 Anti-Chlamydia MIF EUROPattern (IgA) FR 2191-3 A2 refs98/79 Anti-Chlamydia MIF EUROPattern (IgG) FR 2191-3 G2 refs98/79 1 other Anti-Chlamydia MIF EUROPattern (IgM) FR 2191-3 M2 refs98/79	– 98/79	EUDAMED record Report an error
Ebv vca igg	W010504040105	Anti-EBV-CA ChLIA (IgG) LI 2791 G98/79 Anti-EBV-CA ELISA (IgG) EI 2791 G98/79 Anti-EBV-CA IIFT (IgG) FI 2791 G3 refs98/79 Avidity: Anti-EBV-CA-ELISA (IgG) 2 EI 2791-21 G98/79 Avidity: Anti-EBV-CA-ELISA (IgG) EI 2791-1 G98/79 1 other CSF: Anti-EBV-CA-ELISA (IgG) EI 2791-L G98/79	– 98/79	EUDAMED record Report an error
Legionella antibody assays	W0105010502	Anti-Legionella pneumophila ELISA (IgG) EI 2150 G98/79 Anti-Legionella pneumophila ELISA (IgM) EI 2150 M98/79 Anti-Legionella pneumophila Serotype 1 IIFT (IgAGM) FI 2151 P2 refs98/79 IIFT: Legionella Mosaic 7 (IgAGM) FI 2150-7 P98/79 IIFT: Legionella Mosaic 8 (IgAGM) FI 2150-8 P98/79 1 other IIFT: Legionella pneumophila Mix 5 FI 215k-1 P2 refs98/79	– 98/79	EUDAMED record Report an error
Syphilis antibody igm	W0105010304	Anti-Treponema pallidum ELISA (IgM) EI 2111 M98/79 Anti-Treponema pallidum IIFT (IgM) FI 2111 M3 refs98/79 Anti-Treponema pallidum WESTERNBLOT (IgM) DY 2111 M2 refs98/79 Anti-Treponema pallidum WESTERNBLOT (IgM) DY 2112 M2 refs98/79 EUROLINE Anti-Treponema pallidum (IgM) DN 2111 M2 refs98/79 1 other IIFT Mosaic: Treponema pallidum / Treponema phagedenis (IgM) FI 2112 M2 refs98/79	– 98/79	EUDAMED record Report an error
Yersinia	W0105011706	Anti-Yersinia enterocolitica ELISA (IgA) EI 2173 A98/79 Anti-Yersinia enterocolitica ELISA (IgG) EI 2173 G98/79 Anti-Yersinia enterocolitica WESTERNBLOT (IgA) DY 2173 A2 refs98/79 Anti-Yersinia enterocolitica WESTERNBLOT (IgG) DY 2173 G2 refs98/79 EUROLINE Anti-Yersinia enterocolitica (IgA) DN 2173 A2 refs98/79 1 other EUROLINE Anti-Yersinia enterocolitica (IgG) DN 2173 G2 refs98/79	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	Anti-Helicobacter pylori CagA ELISA (IgA) EI 2081 A98/79 Anti-Helicobacter pylori ELISA (IgA) EI 2080 A98/79 Anti-Helicobacter pylori ELISA (IgG) EI 2080 G98/79 Anti-Helicobacter pylori EUROLINE-Westernblot (IgA) DY 2080-1 A2 refs98/79 Anti-Helicobacter pylori EUROLINE-Westernblot (IgG) DY 2080-1 G2 refs98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza	W0105040604	Anti-Influenza A Virus ELISA (IgA) EI 2691 A98/79 Anti-Influenza A Virus ELISA (IgG) EI 2691 G98/79 Anti-Influenza B Virus ELISA (IgA) EI 2692 A98/79 Anti-Influenza B Virus ELISA (IgG) EI 2692 G98/79 Anti-Parainfluenza Viruses Pool ELISA (IgG) EI 2721-1 G98/79	– 98/79	EUDAMED record Report an error
Varicella zoster virus igg	W0105040902	Anti-VZV ELISA (IgG) EI 2650 G98/79 Anti-VZV ELISA 2.0 (IgG) EI 2650-2 G Anti-VZV IIFT (IgG) FI 2650 G2 refs98/79 Avidity: Anti-VZV ELISA (IgG) EI 2650-1 G98/79 CSF: Anti-VZV-ELISA (IgG) EI 2650-L G98/79	C IVDR, 98/79	EUDAMED record Report an error
West nile virus	W0105040626	Anti-West Nile Virus ELISA (IgG) EI 2662 G98/79 Anti-West Nile Virus ELISA (IgM) EI 2662 M98/79 Anti-West Nile virus IIFT (IgG) FI 2662 G2 refs98/79 Anti-West Nile virus IIFT (IgM) FI 2662 M3 refs98/79 Avidity: Anti-West Nile Virus ELISA (IgG) EI 2662-1 G98/79	– 98/79	EUDAMED record Report an error
Cmv igg	W0105040203	Anti-CMV ELISA (IgG) EI 2570 G98/79 Anti-CMV gB ELISA (IgG) EI 2570-3 G98/79 CSF: Anti-CMV ELISA (IgG) EI 2570-L G98/79 EUROLINE Anti-CMV (IgG) DN 2570-2 G3 refs	C IVDR, 98/79	EUDAMED record Report an error
Coronavirus igg	W0105041103	Anti-SARS-CoV-2 ELISA (IgG) EI 2606 G98/79 Anti-SARS-CoV-2 NCP ELISA (IgG) EI 2606-2 G98/79 Anti-SARS-CoV-2 QuantiVac ELISA (IgG) EI 2606-10 G98/79 Anti-SARS-CoV-2 RBD ChLIA (IgG) LI 2606-1 G98/79	– 98/79	EUDAMED record Report an error
Hhv-6,7,8	W0105040624	Anti-HHV-6 IIFT (IgG) FI 2536 G4 refs98/79 Anti-HHV-6 IIFT (IgM) FI 2536 M4 refs98/79 Anti-HHV-6 IIFT EUROPattern (IgG) FR 2536 G4 refs98/79 Anti-HHV-6 IIFT EUROPattern (IgM) FR 2536 M4 refs98/79	– 98/79	EUDAMED record Report an error
Measles virus igg	W0105040702	Anti-Measles Virus ELISA (IgG) EI 2610 G98/79 Anti-Measles Virus ELISA 2.0 (IgG) EI 2610-2 G Avidity: Anti-Measles Virus ELISA (IgG) EI 2610-1 G98/79 CSF: Anti-Measles Virus ELISA (IgG) EI 2610-L G98/79	B IVDR, 98/79	EUDAMED record Report an error
Parasitology - other	W0105050299	Anti-Strongyloides ELISA (IgG) EI 2290 G98/79 Anti-Toxocara ELISA (IgG) EI 2311 G98/79 Anti-Toxocara Westernblot (IgG) DY 2311 G98/79 Anti-Trichinella ELISA (IgG) EI 2360 G	B IVDR, 98/79	EUDAMED record Report an error
Rubella virus igg	W0105040102	Anti-Rubella Virus ELISA (IgG) EI 2590 G98/79 Anti-Rubella Virus ELISA 2.0 (IgG) EI 2590-3 G Avidity: Anti-Rubella Virus ELISA (IgG) EI 2590-1 G98/79 CSF: Anti-Rubella Virus ELISA (IgG) EI 2590-L G98/79	C IVDR, 98/79	EUDAMED record Report an error
Schistosoma	W0105050206	Anti-Schistosoma ELISA (IgG) EI 2300 G98/79 Anti-Schistosoma ELISA (IgM) EI 2300 M98/79 Anti-Schistosoma mansoni IIFT (IgG) FI 2300 G3 refs98/79 Anti-Schistosoma mansoni IIFT (IgM) FI 2300 M98/79	– 98/79	EUDAMED record Report an error
Toxoplasma antibody igg	W0105050102	Anti-Toxoplasma gondii ELISA (IgG) EI 2410 G98/79 Anti-Toxoplasma gondii ELISA 2.0 (IgG) EI 2410-2 G Anti-Toxoplasma gondii IIFT (IgG) FI 2410 G2 refs98/79 CSF: Anti-Toxoplasma gondii ELISA (IgG ) EI 2410-L G98/79	C IVDR, 98/79	EUDAMED record Report an error
Various general purpose IVD instruments - software accessories	W02079082	EUROArrayProcessor Pre-PCR Software YG 0671-2 EUROLabOffice 4.0 YG 0250-7 EUROLabPolaris YG 0251 EUROPicture YG 0011	A IVDR	EUDAMED record Report an error
Virology reagents - other	W01050499	Anti-TBE Virus CSF ELISA 2.0 (IgG) EI 2661-2L G Anti-TBE Virus CSF ELISA 2.0 (IgM) EI 2661-2L M Anti-TBE Virus ELISA 2.0 (IgG) EI 2661-2 G Anti-TBE Virus ELISA 2.0 (IgM) EI 2661-2 M	B IVDR	EUDAMED record Report an error
Adenovirus	W0105040601	Anti-Adenovirus ELISA (IgA) EI 2680 A98/79 Anti-Adenovirus ELISA (IgG) EI 2680 G98/79 Anti-Adenovirus ELISA (IgM) EI 2680 M98/79	– 98/79	EUDAMED record Report an error
Chagas	W0105050202	Anti-Crimean-Congo fever virus(CCHFV) ELISA (IgG) EI 279a G98/79 Anti-Crimean-Congo fever virus(CCHFV) ELISA (IgM) EI 279a M98/79 Anti-Trypanosoma cruzi ELISA (IgG) EI 2212 G98/79	– 98/79	EUDAMED record Report an error
Chlamydia pneumoniae antibody iga	W0105010114	Anti-Chlamydia pneumoniae ELISA (IgA) EI 2192 A98/79 Anti-Chlamydia pneumoniae MIF (IgA) FI 2192-80 A98/79 Anti-Chlamydia pneumoniae MIF EUROPattern (IgA) FR 2192-80 A98/79	– 98/79	EUDAMED record Report an error
Chlamydia pneumoniae antibody igg	W0105010115	Anti-Chlamydia pneumoniae ELISA (IgG) EI 2192 G98/79 Anti-Chlamydia pneumoniae MIF (IgG) FI 2192-80 G98/79 Anti-Chlamydia pneumoniae MIF EUROPattern (IgG) FR 2192-80 G98/79	– 98/79	EUDAMED record Report an error
Chlamydia pneumoniae antibody igm	W0105010116	Anti-Chlamydia pneumoniae ELISA (IgM) EI 2192 M98/79 Anti-Chlamydia pneumoniae MIF (IgM) FI 2192-80 M98/79 Anti-Chlamydia pneumoniae MIF EUROPattern (IgM) FR 2192-80 M98/79	– 98/79	EUDAMED record Report an error
Chlamydia trachomatis antibody iga	W0105010109	Anti-Chlamydia trachomatis Advanced ELISA (IgA) EI 2191-1 A Anti-Chlamydia trachomatis ELISA (IgA) EI 2191 A98/79 Anti-Chlamydia trachomatis MIF (IgA) FI 2191-80 A98/79	C IVDR, 98/79	EUDAMED record Report an error
Chlamydia trachomatis antibody igg	W0105010110	Anti-Chlamydia trachomatis Advanced ELISA (IgG) EI 2191-1 G Anti-Chlamydia trachomatis ELISA (IgG) EI 2191 G98/79 Anti-Chlamydia trachomatis MIF (IgG) FI 2191-80 G98/79	C IVDR, 98/79	EUDAMED record Report an error
Cmv igm	W0105040204	Anti-CMV ELISA (IgM) EI 2570 M98/79 Anti-CMV p52 ELISA (IgM) EI 2570-2 M98/79 EUROLINE Anti-CMV (IgM) DN 2570-2 M3 refs	C IVDR, 98/79	EUDAMED record Report an error
Controls - inf. immunology - other	W0105080899	Negative control for infectious serology blot systems (IgA) CW 2000 ZA98/79 Negative control for infectious serology blot systems (IgG) CW 2000 ZG98/79 Negative control for infectious serology blot systems (IgM) CW 2000 ZM98/79	– 98/79	EUDAMED record Report an error
Coxiella burnetii (q fever)	W0105011703	Anti-Coxiella burnetii Phase 1 ELISA (IgG) EI 217a-1 G98/79 Anti-Coxiella burnetii Phase 2 ELISA (IgG) EI 217a-2 G98/79 Anti-Coxiella burnetii Phase 2 ELISA (IgM) EI 217a-2 M98/79	– 98/79	EUDAMED record Report an error
Ebv vca igm	W010504040104	Anti-EBV-CA ChLIA (IgM) LI 2791 M98/79 Anti-EBV-CA ELISA (IgM) EI 2791 M98/79 Anti-EBV-CA IIFT (IgM) FI 2791 M3 refs98/79	– 98/79	EUDAMED record Report an error
Hsv 1+2 igg	W0105040303	Anti-HSV-1 / HSV-2 gG-2 EUROLINE-WB (IgG) DY 2531-1 G98/79 Anti-HSV-1/2 Pool ELISA (IgG) EI 2531-1 G98/79 CSF: Anti-HSV-1/2 Pool ELISA (IgG) EI 2531-1 L G98/79	– 98/79	EUDAMED record Report an error
Leishmania	W0105050205	Anti-Leishmania donovani IIFT (IgG) FI 2231 G2 refs98/79 Anti-Leishmania donovani IIFT (IgM) FI 2231 M2 refs98/79 Anti-Leishmania ELISA (IgG) EI 2232 G	B IVDR, 98/79	EUDAMED record Report an error
Mumps / parotitis virus igg	W0105040802	Anti-Mumps Virus AT ELISA (IgG) EI 2630-3 G98/79 Anti-Mumps Virus ELISA (IgG) EI 2630 G98/79 CSF: Anti-Mumps Virus ELISA (IgG) EI 2630-L G98/79	– 98/79	EUDAMED record Report an error
Mycoplasma antibody assays	W0105010802	Anti-Mycoplasma pneumoniae ELISA (IgA) EI 2202 A98/79 Anti-Mycoplasma pneumoniae ELISA (IgG) EI 2202 G98/79 Anti-Mycoplasma pneumoniae ELISA (IgM) EI 2202 M98/79	– 98/79	EUDAMED record Report an error
Respiratory syncytial virus (rsv)	W0105040605	Anti-RSV ELISA (IgA) EI 2670 A98/79 Anti-RSV ELISA (IgG) EI 2670 G98/79 Anti-RSV ELISA (IgM) EI 2670 M98/79	– 98/79	EUDAMED record Report an error
Varicella zoster virus igm	W0105040903	Anti-VZV ELISA (IgM) EI 2650 M98/79 Anti-VZV Glycoprotein ELISA (IgM) EI 2650-2 M98/79 Anti-VZV IIFT (IgM) FI 2650 M3 refs98/79	– 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	EUROLabWorkstation ELISA YG 0851 EUROLabWorkstation IFA YG 0852	A IVDR	EUDAMED record Report an error
Brucella	W0105011701	Anti-Brucella abortus ELISA (IgG) EI 2189 G98/79 Anti-Brucella abortus ELISA (IgM) EI 2189 M98/79	– 98/79	EUDAMED record Report an error
Campylobacter reagents - other	W0105011499	Anti-Campylobacter jejuni ELISA (IgA) EI 2091 A98/79 Anti-Campylobacter jejuni ELISA (IgG) EI 2091 G98/79	– 98/79	EUDAMED record Report an error
Chlamydia trachomatis antibody igm	W0105010111	Anti-Chlamydia trachomatis ELISA (IgM) EI 2191-9601 M98/79 Anti-Chlamydia trachomatis MIF (IgM) FI 2191-80 M98/79	– 98/79	EUDAMED record Report an error
Digital laboratory microscopes	W0202050304	EUROPattern Microscope Live YG 0371 EUROPattern Microscope YG 0333	A IVDR	EUDAMED record Report an error
Ebv ea igg	W010504040108	Anti-EBV-EA IIFT (IgG) FI 2795 G2 refs98/79 Anti-EBV-EA-D ELISA (IgG) EI 2795 G98/79	– 98/79	EUDAMED record Report an error
Ebv ea igm	W010504040107	Anti-EBNA IIFT FI 2793 C2 refs98/79 Anti-EBV-EA-D ELISA (IgM) EI 2795 M98/79	– 98/79	EUDAMED record Report an error
Ebv ebna igg	W010504040106	Anti-EBNA-1 ChLIA (IgG) LI 2793 G98/79 Anti-EBNA-1 ELISA (IgG) EI 2793 G98/79	– 98/79	EUDAMED record Report an error
Echinococcus	W0105050204	Anti-Echinococcus ELISA (IgG) EI 2320-1 G98/79 EUROLINE-WB Anti-Echinococcus (IgG) DY 2321-2 G2 refs	B IVDR, 98/79	EUDAMED record Report an error
Fsme virus	W0105040612	Anti-TBE virus IIFT (IgG) FI 2661 G3 refs98/79 Anti-TBE virus IIFT (IgM) FI 2661 M2 refs98/79	– 98/79	EUDAMED record Report an error
Hepatitis virus controls - inf.imm.	W0105080802	Positive control (IgA, human), 50x concentrated CL 2525 A98/79 Positive control (IgG, human), 50x concentrated CL 2525 G98/79	– 98/79	EUDAMED record Report an error
Hsv 1 igg	W0105040306	Anti-Herpes simplex virus 1 ChLIA (IgG) LI 2531 G98/79 Anti-HSV-1 (gC1) ELISA (IgG) EI 2531-2 G98/79	– 98/79	EUDAMED record Report an error
Hsv 1+2 igm	W0105040304	Anti-HSV-1 / HSV-2 gG-2 EUROLINE-WB (IgM) DY 2531-1 M98/79 Anti-HSV-1/2 Pool ELISA (IgM) EI 2531-1 M98/79	– 98/79	EUDAMED record Report an error
Hsv 2 igg	W0105040309	Anti-Herpes simplex virus 2 ChLIA (IgG) LI 2532 G98/79 Anti-HSV-2 (gG2) ELISA (IgG) EI 2532-2 G98/79	– 98/79	EUDAMED record Report an error
Listeria monocytogenes antibody assays	W0105011304	IIFT Mosaic: L. monocytogenes 1/2a / L. monocytogenes 4b (IgG) FI 2141-1 G2 refs98/79 IIFT Mosaic: L. monocytogenes 1/2a / L. monocytogenes 4b (IgM) FI 2141-1 M2 refs98/79	– 98/79	EUDAMED record Report an error
Measles virus igm	W0105040703	Anti-Measles Virus ELISA (IgM) EI 2610 M98/79 Anti-Measles Virus NP ELISA (IgM) EI 2610-4 M98/79	– 98/79	EUDAMED record Report an error
Micro-array instruments - IVD medical device software	W02050292	EUROArrayScan YG 0621 EUROLineScan YG 0006	C IVDR	EUDAMED record Report an error
Mumps / parotitis virus igm	W0105040803	Anti-Mumps Virus ELISA (G5) (IgM) EI 2630-5 M98/79 Anti-Mumps Virus ELISA (IgM) EI 2630 M98/79	– 98/79	EUDAMED record Report an error
Parvovirus b 19	W0105040609	Anti-Parvovirus B19 ELISA (IgG) EI 2580 G98/79 Anti-Parvovirus B19 ELISA (IgM) EI 2580 M98/79	– 98/79	EUDAMED record Report an error
Syphilis antibody assays total	W0105010302	Anti-Treponema pallidum ELISA 2.0 (IgGM) EI 2111-2 O Anti-Treponema pallidum Screen ELISA (IgGM) EI 2111 O98/79	C IVDR, 98/79	EUDAMED record Report an error
Toxoplasma antibody igm	W0105050103	Anti-Toxoplasma gondii ELISA (IgM) EI 2410 M98/79 Anti-Toxoplasma gondii IIFT (IgM) FI 2410 M2 refs98/79	– 98/79	EUDAMED record Report an error
Aspergillus	W0105060301	Aspergillus Antigen ELISA EQ 691198/79	– 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - IVD medical device software	W0201020192	EUROPattern Classifier YG 0071	B IVDR	EUDAMED record Report an error
Cmv igg - avidity	W0105040206	Avidity: Anti-CMV ELISA (IgG) EI 2570-1 G98/79	– 98/79	EUDAMED record Report an error
Coronavirus ag	W0105041101	Anti-MERS-CoV ELISA (IgG) EI 2604 G98/79	– 98/79	EUDAMED record Report an error
Coronavirus iga	W0105041105	Anti-SARS-CoV-2 ELISA (IgA) EI 2606 A98/79	– 98/79	EUDAMED record Report an error
Devices for samples analyses - other	W05039099	TITERPLANE reagent tray for EUROArray slides ZM 9999-R	A IVDR	EUDAMED record Report an error
Diphtheria (corynebacterium d.)	W0105011708	Anti-Diphtheria Toxoid ELISA (IgG) EI 2040 G98/79	– 98/79	EUDAMED record Report an error
Gram+ - gram- - fungi - multiplex NA reagents	W0105070201	EUROArray Dermatomycosis MN 28504 refs98/79	– 98/79	EUDAMED record Report an error
Hev antibody igg	W0105020504	Anti-Hepatitis E Virus (HEV) ELISA (IgG) EI 2525 G98/79	– 98/79	EUDAMED record Report an error
Hev antibody igm	W0105020505	Anti-Hepatitis E Virus (HEV) ELISA (IgM) EI 2525 M98/79	– 98/79	EUDAMED record Report an error
Hev reagents - other	W0105020599	EUROLINE Anti-Hepatitis E Virus (IgA) DN 2525 A3 refs98/79	– 98/79	EUDAMED record Report an error
IVD instruments - other	W0299	Microwell Imager YG 0191	A IVDR	EUDAMED record Report an error
Lyme antibody total	W0105010602	Lyme ELISA (IgG/IgM) EI 2132-24 O98/79	– 98/79	EUDAMED record Report an error
Micro-array scanners	W02050107	EUROArrayScanner YG 0602	A IVDR	EUDAMED record Report an error
Nucleic acid hybridization units	W02050101	EUROArrayProcessor YG 0671-1	A IVDR	EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - software accessories	W02050182	ERUORealTime Analysis YG 0661	A IVDR	EUDAMED record Report an error
Optical laboratory microscopes	W0202050303	EUROStar IV Plus YG 0307	A IVDR	EUDAMED record Report an error
Parasitology controls - inf.imm.	W0105080805	Pos. control: anti-Echinococcus (IgG), 50x concentrate CW 2321 G98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria)	W0105050209	Anti-Plasmodium ELISA (IgG) EI 2260 G98/79	– 98/79	EUDAMED record Report an error
Rubella virus igm	W0105040103	Anti-Rubella Virus Glycoprotein ELISA (IgM) EI 2590-2 M98/79	– 98/79	EUDAMED record Report an error
Screening high-risk HPV - NA reagents	W0105041002	EUROArray HPV MN 25404 refs98/79	– 98/79	EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	EUROArray STI - 11 MN 28304 refs98/79	– 98/79	EUDAMED record Report an error
Tetanus (clostridium t.)	W0105011709	Anti-Tetanus Toxoid ELISA (IgG) EI 2060 G98/79	– 98/79	EUDAMED record Report an error
Toxoplasma - NA reagents	W0105050105	EURORealTime Toxoplasma gondii MP 24102 refs	C IVDR	EUDAMED record Report an error
Toxoplasma antibody igg - avidity	W0105050104	Avidity: Anti-Toxoplasma gondii ELISA (IgG) EI 2410-1 G98/79	– 98/79	EUDAMED record Report an error
Toxoplasma reagents - other	W0105050199	Anti-Toxoplasma gondii ELISA (IgA) EI 2410 A98/79	– 98/79	EUDAMED record Report an error
Varicella zoster virus reagents - other	W0105040999	Anti-VZV ELISA (IgA) EI 2650 A98/79	– 98/79	EUDAMED record Report an error
Various general purpose IVD instruments - IVD medical device software	W02079092	EUROLabCSF YG 0259-1	A IVDR	EUDAMED record Report an error

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