Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021562887

FEI Number

3021562887

Entity Name

QTREX Quantum Ltd

City/State/Country

Ra'anana Central, IL

Establishment Address

2, Ha-Tidhar, Ra'anana Central 4366504, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

QTREX QUANTUM Ltd. (Owner Number: 10083402)

Owner / Operator Contact Address

2 Ha-Tidhar St., Ra'anana, IL-M 4366504, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

INSPIRA ART100 Cannula Fixation Device INSPIRA CART

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWA	Control, Pump Speed, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4380	2024-05-30
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2022-01-27
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	Class 1	870.4200	2024-08-22

Official Correspondent

Avi Shabtay

US Agent Details

George Hattub Business: Medicsense USA LLC Email: ghattub@comcast.net Phone: (508) 4796116

Related Public Records

Same Entity

QTREX QUANTUM 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 3021562887. Last updated year: 2026. Please use registration number 3021562887 when referencing this establishment in official correspondence.