Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013922904

FEI Number

3013922904

Entity Name

DREAMED DIABETES LTD

City/State/Country

Petah Tikva Tel Aviv, IL

Establishment Address

14 Kaplan St. The Endocrinology Center, Schneider Childrens Medical Center, Petah Tikva Tel Aviv 4920235, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dreamed Diabetes Ltd (Owner Number: 10058055)

Owner / Operator Contact Address

14 Kaplan Street, The Endocrinology Center Schneider Children Medical Center, Petah Tikva, IL-TA 4920235, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210561

PMA Number

N/A

All Registered Proprietary Names

Device Device Device Device Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QCC	Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals	Clinical Chemistry	Class 2	862.1358	2019-11-19
PHV	Continuous Glucose Monitor Retrospective Data Analysis Software	Clinical Chemistry	Class 1	862.2120	2019-06-01
QCC	Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals	Clinical Chemistry	Class 2	862.1358	2018-07-01
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2019-05-27
NDC	Calculator, Drug Dose	Anesthesiology	Class 2	868.1890	2021-12-11
QCC	Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals	Clinical Chemistry	Class 2	862.1358	2021-12-11

Official Correspondent

Adi Berkovitch

US Agent Details

George Hattub Business: Medicsense USA Email: ghattub@comcast.net Phone: (508) 4796116

Related Public Records

Same Entity

Dreamed Diabetes Ltd

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013922904. Last updated year: 2026. Please use registration number 3013922904 when referencing this establishment in official correspondence.