Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003993868

FEI Number

3003993868

Entity Name

MIZRA MEDICAL LTD.

City/State/Country

HOLON Tel Aviv, IL

Establishment Address

21 HASADNA STREET, INDUSTRIAL ZONE, HOLON Tel Aviv 5881411, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MIZRA MEDICAL LTD. (Owner Number: 9074799)

Owner / Operator Contact Address

21 HASADNA STREET, --, HOLON, IL-NOTA 5881411, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Uro-Sheath ESTHESIOMETER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNX	Device, Incontinence, Urosheath Type, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2005-06-30
GXB	Esthesiometer	Neurology	Class 1	882.1500	2005-06-30

Official Correspondent

DROR MIZRA

US Agent Details

Raymond Halsey-Franke Business: Urocare Products, Inc. Email: ops@urocare.com Phone: (909) 6216013

Related Public Records

Same Entity

MIZRA MEDICAL LTD.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3010400865	WELL LEAD MEDICAL CO. LTD	GUANGZHOU Guangdong, CN
3008262278	Coloplast Hungary, KFT	Tatabanya, HU
3005609751	Forsure Medical Products LLC.	Doral, FL, US
3014982318	HONG MING ENTERPRISE CO., LTD.	Taichung City, TW
3004450493	MRK HEALTHCARE PVT.LTD	PATAN Gujarat, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003993868. Last updated year: 2026. Please use registration number 3003993868 when referencing this establishment in official correspondence.