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MEDINOL LTD.

Israel·IL-MF-000013929

Last updated September 17, 2026

Information

Country: Israel
Address: 8, Beck-Tech Building, Har Hotzvim B, Hartom St., Jerusalem, Israel
Website: www.medinol.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: (720) 386 5585
PRRC Contact: Marina Tikhonov-Demishtein
EUDAMED SRN: IL-MF-000013929
FDA FEI Number: 3003182398
DUNS Number: 600593800

Catalogue (250)

Page 5 of 5

Device	Model / Reference	Registries	Class	Status
NC Gallant™ PTCA Catheter	NCG225R06US	FDA UDI	Class II	Active
X-Suit Nir Biliary Metallic Stent	SME-200P-10100	FDA UDI	Class II	Active
NC Gallant™ PTCA Catheter	NCG450R20US	FDA UDI	Class II	Active
EluNIR-PERL Ridaforolimus Eluting Coronary Stent System	ELM400R08US	FDA UDI	Class III	Active
EluNIR Ridaforolimus Eluting Coronary Stent System	LUN400R08US	FDA UDI	Class III	Unknown
EluNIR-PERL Ridaforolimus Eluting Coronary Stent System	ELM350R17US	FDA UDI	Class III	Active
EluNIR-PERL Ridaforolimus Eluting Coronary Stent System	ELM250R20US	FDA UDI	Class III	Active
EluNIR Ridaforolimus Eluting Coronary Stent System	LUN300R20US	FDA UDI	Class III	Unknown
NC Gallant™ PTCA Catheter	NCG325R15US	FDA UDI	Class II	Active
EluNIR Ridaforolimus Eluting Coronary Stent System	LUN250R08US	FDA UDI	Class III	Unknown
NC Gallant™ PTCA Catheter	NCG225R08US	FDA UDI	Class II	Active
EluNIR idaforolimus Eluting Coronary Stent System	LUN350R12US	FDA UDI	Class III	Unknown
EluNIR Ridaforolimus Eluting Coronary Stent System	LUN275R28US	FDA UDI	Class III	Unknown
NC Gallant™ PTCA Catheter	NCG500R20US	FDA UDI	Class II	Active
EluNIR Ridaforolimus Eluting Coronary Stent System	LUN400R17US	FDA UDI	Class III	Unknown
EluNIR-PERL Ridaforolimus Eluting Coronary Stent System	ELM225R08US	FDA UDI	Class III	Active
EluNIR-PERL Ridaforolimus Eluting Coronary Stent System	ELM250R12US	FDA UDI	Class III	Active
EluNIR-PERL Ridaforolimus Eluting Coronary Stent System	ELM350R33US	FDA UDI	Class III	Active
EluNIR-PERL Ridaforolimus Eluting Coronary Stent System	ELM400R20US	FDA UDI	Class III	Active
EluNIR-PERL Ridaforolimus Eluting Coronary Stent System	ELM225R12US	FDA UDI	Class III	Active
EluNIR-PERL Ridaforolimus Eluting Coronary Stent System	ELM350R15US	FDA UDI	Class III	Active
EluNIR-PERL Ridaforolimus Eluting Coronary Stent System	ELM350R38US	FDA UDI	Class III	Active
EluNIR-PERL Ridaforolimus Eluting Coronary Stent System	ELM275R17US	FDA UDI	Class III	Active
EluNIR-PERL Ridaforolimus Eluting Coronary Stent System	ELM225R33US	FDA UDI	Class III	Active
EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System	ELM300R17IN	EUDAMED	Class III	Active
EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System	ELM350R28IN	EUDAMED	Class III	Active
EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System	ELM350R44IN	EUDAMED	Class III	Active
Nir Biliary Stent	K002130	FDA 510(k)	Class II	Active
Medinol X-Suit Nir Biliary Metallic Stent	K081956	FDA 510(k)	Class II	Active
X-Suit NIR Biliary Metallic Stent	K150487	FDA 510(k)	Class II	Active
Gallant PTCA Dilatation Catheter	K173581	FDA 510(k)	Class II	Active
NC Gallant PTCA Catheter	K162434	FDA 510(k)	Class II	Active
Nir Biliary Stent	K973171	FDA 510(k)	Class II	Active
EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System	ELM275R20IN	EUDAMED	Class III	Active
EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System	ELM400R20IN	EUDAMED	Class III	Active
EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System	ELM350R33IN	EUDAMED	Class III	Active
EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System	ELM275R28IN	EUDAMED	Class III	Active
EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System	ELM250R17IN	EUDAMED	Class III	Active
EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System	ELM400R33IN	EUDAMED	Class III	Active
EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System	ELM400R08IN	EUDAMED	Class III	Active
EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System	ELM300R24IN	EUDAMED	Class III	Active
EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System	ELM400R28IN	EUDAMED	Class III	Active
EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System	ELM350R24IN	EUDAMED	Class III	Active
EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System	ELM225R28IN	EUDAMED	Class III	Active
EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System	ELM225R12IN	EUDAMED	Class III	Active
EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System	ELM300R08IN	EUDAMED	Class III	Active
Nirflex Premounted Coronary Stent System	P020040	FDA PMA	Class III	Active
NIRxcell CoCr Coronary Stent on RX System	P110004	FDA PMA	Class III	Active
EluNIR Ridaforolimus Eluting Coronary Stent System	P170008	FDA PMA	Class III	Active
EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System	ELM300R38IN	EUDAMED	Class III	Active

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