Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012239564

FEI Number

3012239564

Entity Name

BLUEWIND MEDICAL LTD.

City/State/Country

Herzliya Tel Aviv, IL

Establishment Address

4 Maskit Street, Building C, Eastern Side, Herzliya Tel Aviv 4614002, IL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

BlueWind Medical Ltd. (Owner Number: 10088572)

Owner / Operator Contact Address

250 E 200 S, Site 1600, Salt Lake City, UT 84111, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN220073

PMA Number

N/A

All Registered Proprietary Names

Revi System Revi Clinician Program Revi Wearable Revi System Revi Wearable Revi Implant Revi System Revi Hub Revi Clinician Program

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QXM	Implanted Tibial Electrical Urinary Continence Device	Gastroenterology, Urology	Class 2	876.5305	2024-05-03
QXM	Implanted Tibial Electrical Urinary Continence Device	Gastroenterology, Urology	Class 2	876.5305	2026-01-07
QXM	Implanted Tibial Electrical Urinary Continence Device	Gastroenterology, Urology	Class 2	876.5305	2023-08-17

Official Correspondent

Angel Estrada

US Agent Details

Angel Estrada Business: BlueWind Medical Email: angel.estrada@bluewindmedical.com Phone: (702) 7236889

Related Public Records

Same Entity

BlueWind 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
3038988751	Bluewind Medical, Inc.	Salt Lake City, UT, US

Similar Registrations

Registration Number	Establishment Name	Location
3038988751	Bluewind Medical, Inc.	Salt Lake City, UT, US
3011606051	PLEXUS SERVICES RO SRL	Oradea Bihor, RO
3008729892	MEDIPLAST ISRAEL LTD	Yavne Tel Aviv, IL
3003923762	OSYPKA GmbH	Rheinfelden Baden-Wurttemberg, DE
3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012239564. Last updated year: 2026. Please use registration number 3012239564 when referencing this establishment in official correspondence.