MEDINOL LTD.

FDA Device Registration & Listing · Jerusalem, IL · Registration 3003084171

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003084171
FEI Number
3003182398
Entity Name
MEDINOL LTD.
City/State/Country
Jerusalem, IL
Establishment Address
8 Hartom Street Beck Tech Bldg. Har Hotzvim B,, Jerusalem 9777508, IL
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
MEDINOL LTD. (Owner Number: 9031416)
Owner / Operator Contact Address
Kiryat Atidim, Bldg. 8, Tel Aviv, IL-TA 6158101, IL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P170008

All Registered Proprietary Names

NC Gallant PTCA Dilatation Catheter Gallant PTCA Dilatation Catheter EluNIR™ Ridaforolimus Eluting Coronary Stent System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2017-01-22
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2018-06-24
NIQ Coronary Drug-Eluting Stent Unknown Class 3 N/A 2017-11-30

Official Correspondent

No official correspondent registered.

US Agent Details

H. Semih Oktay Business: CardioMed Device Consultants, LLC Email: soktay@cardiomedllc.com Phone: (410) 6742060

Related Public Records

Same Entity

MEDINOL LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9710284 MEDINOL LTD. TEL-AVIV Tel Aviv, IL

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-04 N/A 2
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Z-0031-04 N/A 2
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Z-0032-04 N/A 2
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003084171. Last updated year: 2026. Please use registration number 3003084171 when referencing this establishment in official correspondence.
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