Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029779285

FEI Number

3029779285

Entity Name

LIMACA MEDICAL LTD

City/State/Country

Ein Ha Emeq Haifa, IL

Establishment Address

3 Ha' Rimon st, Regev Bldg., Mevo Carmel High Tech Park, Ein Ha Emeq Haifa 1925000, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Limaca medical Ltd (Owner Number: 10088881)

Owner / Operator Contact Address

3 Ha' Rimon st, Regev Bldg., Mevo Carmel High Tech Park, Ein Ha Emeq, IL-HA 1925000, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231422

PMA Number

N/A

All Registered Proprietary Names

PRECISION GI 20GA Motorized EUS Biopsy Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2023-10-18

Official Correspondent

Assaf Klein

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: customerservices@dawamedical.com Phone: (786) 7311159

Related Public Records

Same Entity

Limaca medical Ltd

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150891	Covidien, LLC( Formerly Beacon Endoscopic Corp.)	BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System	2015-05-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2012	Olympus America Inc.	2	OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.

Similar Registrations

Registration Number	Establishment Name	Location
3042940295	NEONAVIA AB	Vallentuna Stockholm, SE
3016678045	Schneider ASR B.V.	Rotterdam-Albrandswaard Zuid-Holland, NL
3005099803	BOSTON SCIENTIFIC CORPORATION	Marlborough, MA, US
1828132	BOSTON SCIENTIFIC CORPORATION	SPENCER, IN, US
3010188783	JAPAN GAS COMPANY LIMITED	YOKOHAMA Kanagawa, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029779285. Last updated year: 2026. Please use registration number 3029779285 when referencing this establishment in official correspondence.