Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005261802

FEI Number

3005261802

Entity Name

SMART MEDICAL SYSTEMS LTD.

City/State/Country

Raanana Central, IL

Establishment Address

5 Hanofar Str., Raanana Central 4366404, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Smart Medical Systems Ltd. (Owner Number: 10025066)

Owner / Operator Contact Address

5 Hanofar Street, Raanana, IL-M 4366404, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112106

PMA Number

N/A

All Registered Proprietary Names

NaviAid¿ SPARK NaviAid¿ ABC Operation Kit NaviAid¿ BGC Disposable NaviAid¿ ABC Disposable NaviAid¿ Single Balloon Air Supply Unit NaviAid¿ BGC Operation Kit NAVIAID ICVI-F,S,B,R DEVICE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2011-09-18
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2014-06-19

Official Correspondent

Ahava Stein

US Agent Details

NAPHTALI DEUTSCH Email: ahava@asteinrac.com Phone: (888) 4433867

Related Public Records

Same Entity

Smart Medical Systems Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005261802. Last updated year: 2026. Please use registration number 3005261802 when referencing this establishment in official correspondence.