Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015921024

FEI Number

3015921024

Entity Name

HEALTHY.IO LTD.

City/State/Country

Tel Aviv-Yafo, IL

Establishment Address

40, Ha-Masger, Tel Aviv-Yafo 6721122, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Healthy.io Ltd. (Owner Number: 10062175)

Owner / Operator Contact Address

40 Hamasger st, Tel Aviv, IL-TA 6721122, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222921

PMA Number

N/A

All Registered Proprietary Names

Minuteful for Wound Minuteful - kidney test Minuteful - Kidney Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXN	Tape, Camera, Surgical	General, Plastic Surgery	Class 1	878.4160	2019-12-26
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2022-09-19
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2022-09-19
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2022-09-19
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2024-12-18
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2024-12-18
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2024-12-18

Official Correspondent

No official correspondent registered.

US Agent Details

Ron Zohar Email: ron@healthy.io Phone: (646) 7393051

Related Public Records

Same Entity

Healthy.io 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
K012065	Wiener Laboratories Saic	WIENER LAB. CREATININA CINETICA AA	2001-10-10
K183555	Instrumentation Laboratory CO	GEM Premier ChemSTAT	2019-02-16
K090330	Siemens Healthcare Diagnostics, Inc.	DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270	2009-05-22
K212223	Siemens Healthcare Diagnostics, Inc.	Atellica CH Enzymatic Creatinine_3 (ECre3)	2021-11-24
K101852	Iris International Inc., A Division of Iris Iris I	CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT	2011-03-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2009	Roche Diagnostics Corp.	2	Roche Diagnostics CREP2, Creatinine Plus Ver. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03263991190. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of creatine in serum, urine and plasma.

Similar Registrations

Registration Number	Establishment Name	Location
3009129626	WOUNDMATRIX, INC.	Chadds Ford, PA, US
3010490821	TRUE-SEE SYSTEMS, Inc	New Orleans, LA, US
3010621964	ATLAS MEDICAL PRODUCTS LLC	Hialeah, FL, US
3039395626	ADIUVO DIAGNOSTICS PRIVATE LIMITED	Visakhapatnam Andhra Pradesh, IN
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015921024. Last updated year: 2026. Please use registration number 3015921024 when referencing this establishment in official correspondence.