Regulatory Information

About

LibreView
Version 3.0.2


(01) 00860000502016

(8012) 3.0.2

LibreLinkUp Mobile App
Version 2.6.0


(01) 00860000502009

(8012) 2.6.0



https://www.libreview.com

http://librelinkup.com

LibreView Website

LibreLinkUp Mobile App

Foreword

Safety and efficacy are key cornerstones in the design and support of the LibreView system. Newyu takes its responsibilities as a medical device manufacturer seriously.

In many regions, LibreView includes the LibreView website and LibreLinkUp mobile app.

Intended Use

LibreView is intended for use by both patients and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis and evaluation of historical glucose meter data to support effective diabetes management.

In other words, LibreView is a secondary viewer and is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.

This device is not intended to replace self-monitoring practices as advised by a physician.

Home users should consult a healthcare professional before making any medical interpretation and therapy adjustments from the information in the software.

Healthcare professionals should use information in the software in conjunction with other clinical information available to them.

When using the LibreLinkUp mobile app:
Patients should not rely on caregivers to notify them about low or high glucose.

Any problems with the mobile device, NFC, wireless internet connection, mobile data connection, LibreLink or FreeStyle LibreLink, LibreLinkUp or LibreView could cause data to not be shared with caregivers, or delay transmission to caregivers.

LibreView (and thus LibreLinkUp) should be used only to give a secondary level of awareness and should not be expected to always communicate and transfer sensor glucose information.

Quality Management

ISO (International Organization for Standardization) 13485

LibreView services are considered a medical device in many global countries and regions. Alongside our security program, Newyu has achieved ISO (International Organization for Standardization) 13485 certification for our Quality Management Systems (QMS), covering our medical devices and related activities. ISO 13485 is a globally recognized quality standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Our certification encompasses our product life-cycle, including design and development, production, storage and distribution, and support.

21 Code of Federal Regulations (CFR) Part 820

The United States maintains one of the world’s most robust set of legislation and guidance concerning medical devices. There are similarities to ISO 13485 but also many differences. As a US-based device manufacturer, Newyu maintains compliance with the US Quality System Regulations (QSR) and registers our establishment with the FDA annually.

Global Regulatory Representatives

Newyu maintains our Quality Management System for our global product in support of regional registrations or approvals as required to place the device on the market.

Shown below are in-country representatives for regulatory affairs issues and incident reporting, including Newyu partners, sponsors or representatives where applicable.

If a country is available from the product as a country for registration, but is not listed below, most likely it is not a medical device or does not require registration in that country. Please contact LibreView support with any questions.


Manufacturer

Newyu, Inc., 3452 Lake Lynda Dr. Suite 352, Orlando, FL 32817 USA


ARGENTINA

Class 1 device, Argentina Representative ABBOTT LABORATORIES ARGENTINA

PM number: 39-703


Australia

Class 1 device, Australian Sponsor:

EMERGO AUSTRALIA, Level 20, Tower II, Darling Park, 201 Sussex Street, Sydney, NSW 2000, Australia

ARTG ID: 296121


BRAZIL

Class II device, Brazil Importer of Record: Emergo Brazil Import Imp Distr de Prod Méd Hosp Ltda., CNPJ: 04.967.408/0001-98

Av. Francisco Matarazzo, 1.752, Salas 502/503, Água Branca, São Paulo-SP, CEP – 05001-200

BRAZILVIGILANCE@UL.COM

Resp Téc: Luiz Levy CRF-SP: 42415

ANVISA: 80117580705


COLOMBIA

Class IIa device, Colombia Importer of Record: Impomed S.A.S.

INVIMA registration number: IMVIMA 2018DM-008191


Europe

Class 1 device, EU Authorized Representative:

EMERGO EUROPE, Prinsessegracht 20, 2514 AP The Hague, The Netherlands


Israel

Class 1 device, Israeli Registration Holder:

I.L.Emergo Israel Ltd., Tel: 02-6731634, 9 Andrei Sakharov St., Matam, P.O.B. 15401, Haifa 3190501

AMAR registration number: 24820088


NEW ZEALAND

Class 1 device, New Zealand Sponsor: CLINICAL & REGULATORY SERVICES LIMITED (CARSL)

WAND Reference: 171216-WAND-6PFS9Z


Saudi Arabia

Class 1 device, Saudi Authorized Representative:

MEDICAL SUPPLIES & SERVICE CO. LTD MEDISERV


Singapore

Class A Exempt device, contact Manufacturer as above, imported by ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED


Turkey

Class 1 Exempt device, contact Manufacturer as above