ENA SCREENING

EMDN W0102100102

Parent W01021001 AUTOIMMUNE CONNECTIVE TISSUE DISEASES

Registry term list. Not a clinical opinion. 40 devices carry this code.

Devices

Name	UDI-DI	Manufacturer	Class	Badge
AESKULISA® ENA-6Pro	04250289500456	Aesku.Diagnostics GmbH & Co. KG	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AESKULISA® ENA-6S	04250289500449	Aesku.Diagnostics GmbH & Co. KG	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AESKULISA® ENA-6 Stripes	04250289503495	Aesku.Diagnostics GmbH & Co. KG	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
BioCLIA Autoimmune Calibrator Set, ENA Screen I	06924030403645	HOB Biotech Group Corp., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
BioCLIA Autoimmune Control Set, ENA Screen I	06924030404666	HOB Biotech Group Corp., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
BioCLIA Autoimmune Reagent Kit, ENA Screen I	06924030403133	HOB Biotech Group Corp., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
BioCLIA Autoimmune Reagent Kit, ENA Screen I	06924030415907	HOB Biotech Group Corp., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
BlueDiverDot ENA6 IgG	05425023681442	D-tek s.a.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
BlueDot ENA6 IgG	05425023680414	D-tek s.a.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
CHORUS ENA-6 S	08033891323134	DIESSE Diagnostica Senese S.p.A	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
CHORUS ENA-6 S	08033891329129	DIESSE Diagnostica Senese S.p.A	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
CLIA ENA screen plus	08595635309748	TestLine Clinical Diagnostics s.r.o.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
DiaSpot ENA6 IgG	05425023688045	D-tek s.a.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
DIASpot Neptune ENA 6 IgG	05425023688199	D-tek s.a.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
EIA ENA profile plus	08595635307607	TestLine Clinical Diagnostics s.r.o.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
EIA ENA screen plus	08595635300769	TestLine Clinical Diagnostics s.r.o.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
ENA Assay Kit (Fluorescence Immunoassay)	06975424225206	DiYaLab ZJG Biotech Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
ENA Assay Kit (Fluorescence Immunoassay)	06975424225992	DiYaLab ZJG Biotech Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
ENA Dot	05425023687116	D-tek s.a.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
ENA Dot for BDI	05425023687413	D-tek s.a.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
ENA-LISA	03532672001339	BIOSYNEX	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
ENA Profile	04260158680035	AIDA GmbH	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
ENA screen	86060147192914	NEOMEDICA DOO NIŠ	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
ENA Screen	04260158680028	AIDA GmbH	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
ENA Screen 6 ELISA	04049325004443	IBL International GmbH	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
ENA Screen FIA Kit	06974674892251	Shenzhen Zijian Biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Evo Autoimmune SPA	48058945154708	ABD SRL	Class A	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
IDS ENA Screen	05060169693777	Immunodiagnostic Systems Limited	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
iFlash-ENA	06925912735496	SHENZHEN YHLO BIOTECH CO., LTD.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
iFlash-ENA	06925912736622	SHENZHEN YHLO BIOTECH CO., LTD.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
iFlash-ENA	06925912739456	SHENZHEN YHLO BIOTECH CO., LTD.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies	06924030400965	HOB Biotech Group Corp., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
MASTAZYME™ ENA Screen 7	04250729700330	Mast Diagnostica GmbH	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
QUANTA Flash	08426950566373	Inova Diagnostics. Inc.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
QUANTA Flash	08426950627821	Inova Diagnostics. Inc.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Sharay ENA Screen IgG (CLIA)	06975070765385	C-Luminary Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Sharay ENA Screen IgG (CLIA)	06975070769826	C-Luminary Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
SmartEIA ENA profile plus	08595635307591	TestLine Clinical Diagnostics s.r.o.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
SmartEIA ENA screen plus	08595635306082	TestLine Clinical Diagnostics s.r.o.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
ZENIT RA ENA Screen	08054320950424	Technogenetics S.p.A	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED