Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616787

FEI Number

3006654321

Entity Name

MEDISIM LTD.

City/State/Country

Ness Ziona Central, IL

Establishment Address

5 Professor Avraham Patchornik Street, 6th Floor, Building A, Ness Ziona Central 7413014, IL

Establishment Type(s)

Remanufacture Medical Device,Foreign Private Label Distributor,Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

MEDISIM LTD. (Owner Number: 9035477)

Owner / Operator Contact Address

6th Floor, Building A, 5 Professor Avraham Patchornik Street, Ness Ziona, IL-NOTA 7413014, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K983887

PMA Number

N/A

All Registered Proprietary Names

TTP Temple Touch Pro Forehead THEROMETER FHT1- Temple Touch Mini Temple touch FHT6 Mother's touch FHT5 Swan FHT2 - Temple Touch Premium Up-Grade thermometer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2016-11-03
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2008-01-13
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2008-01-13
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2014-02-23

Official Correspondent

Ilan Vadai

US Agent Details

John Wilson Business: President Medisim USA Inc. Email: john.wilson@medisim-usa.com Phone: (847) 6822791

Related Public Records

Same Entity

MEDISIM 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
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616787. Last updated year: 2026. Please use registration number 9616787 when referencing this establishment in official correspondence.