EQUASHIELD MEDICAL LTD

FDA Device Registration & Listing · Migdal Tefen Northern, IL · Registration 3008349578

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
3008349578
FEI Number
3008349578
Entity Name
EQUASHIELD MEDICAL LTD
City/State/Country
Migdal Tefen Northern, IL
Establishment Address
Ktalav St.1, POB 12, Migdal Tefen Northern 2495900, IL
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
EQUASHIELD MEDICAL LTD (Owner Number: 10032271)
Owner / Operator Contact Address
Ktalav St.1, POB 12, Migdal Tefen, IL-Z 2495900, IL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Sampling Kit Syringe CellSHIELD®

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2018-02-27
KJG Tube, Tissue Culture Pathology Class 1 864.3010 2022-01-20
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2017-12-03
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2023-04-24

Official Correspondent

Michal Levy

US Agent Details

Evan Schweitzer Business: EQUASHIELD LLC Email: evan.s@equashield.com Phone: (516) 6848200

Related Public Records

Same Entity

EQUASHIELD MEDICAL 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
3008468447 EQUASHIELD MEDICAL LTD Tefen Northern, IL

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2008 Beckman Coulter Inc 1
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013 Biomerieux Inc 1
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008349578. Last updated year: 2026. Please use registration number 3008349578 when referencing this establishment in official correspondence.
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