Déclaration de conformité UE pour Dia-Band Night And Day Adultes

Product catalog summary

EU Declaration of Conformity Overview

This document is an EU Declaration of Conformity for the Kaio-Dia® Dia-Band Night & Day©, a non-invasive arm sleeve designed to provide additional fixation support for various medical devices. It is issued by CV. Anggrek-Liar, located in Semarang, Central Java, Indonesia, with Kaio-Dia Europe Sasu as the EU Authorized Representative in France.

Specifications and Compliance

The product is classified under Class I according to the medical device regulation 2017/745 (EU MDR).
It is intended for use as an accessory for devices like CGM and insulin patch pumps, providing additional support to devices attached to the skin with adhesive.
The arm sleeves are available in adult sizes, non-sterile, reusable, and intended for single patient use only.

Technical Documentation

Reference: DOC333ABA56272
The declaration supersedes a previous version dated 01-December-2021.

Manufacturing and Registration Details

Manufacturing sites are located in Semarang, Central Java, Indonesia.
Single Registration Numbers (SRN): ID-MF-000037819 (Indonesia) and FR-AR-000037267 (France).

Supported Products

The arm sleeves support a range of products including Abbot Freestyle Libre 2 and 3, Dexcom G6 and G7, Insulet Omnipod 5 and Dash, Medtrum EasySense 7.1, Menarini GlucoMen Day CGM and Pump, Medtronic Guardian sensors 3 and 4, and Sibionics GS1 CGM.

Catalog excerpts

Déclaration de conformité UE pour Dia-Band Night And Day Adultes-1

EU DECLARATION OF CONFORMITY Document number: ALABA333101220208 Following the provisions of the medical device’s regulation 2017/745 (EU MDR). We: Legal Manufacturer CV. Anggrek-Liar Jalan Jomblang Barat 666 RT 09 RW 03 Kelurahan Candi, Kecamatan Candisari Semarang 50257 Central Java REPUBLIC OF INDONESIA EU Authorized Representative Kaio-Dia Europe Sasu 12, rue Bertrand 31480 Lagraulet Saint Nicolas, France Single Registration Number (SRN) ID-MF-000037819 Single Registration Number (SRN) FR-AR-000037267 Manufacturing Sites Anggrek-Liar / Kaio-Care Jalan Tumpang IV No. 38 Kelurahan Bendan Ngisor Kecamatan Gajahmungkur Semarang 50233 Central Java REPUBLIC OF INDONESIA Declare under our sole responsibility for the universal device fixation support: Kaio-Dia® Dia-Band Night & Day© Non-Invasive Arm Sleeves Basic UDI-DI: 8994228UA-ABA12-NDW4 Identification number: See Appendix 1 Date: 01 July 2024 SIGNATURE: Date of Issue Place of Issue Name Function Semarang, Central Java, Indonesia Anik Susilawatiningsih Regulatory Affairs Manager This Declaration of Conformity relating to Technical Documentation DOC333ABA56272 supersedes the previous Declaration signed 01-December-2021.

Open the catalog to page 1

Déclaration de conformité UE pour Dia-Band Night And Day Adultes-2

Intended Purpose: Kaio-Dia® Dia-Band Night & Day©, arm sleeves are independently developed as universal after market accessories used to provide additional fixation support for a wide variety of medical devices, such as CGM and insulin patch pump, that in their native forms are attached to the skin with an adhesive fixation. (see attachment Appendix 1 – List of Supported Product version #3) Dia-Bands Night & Day© are available in adult sizes and several color are non-sterile and may be reused (intended for single patient use only). The devices are not designed or sold for use other than indicated....

Open the catalog to page 2

Déclaration de conformité UE pour Dia-Band Night And Day Adultes-3

Appendix 1 - List of Supported Product Date 01-07-2024 version #003 Date of Issue Place of Issue Name Function Semarang, Central Java, Indonesia Anik Susilawatiningsih Regulatory Affairs Manager This Declaration of Conformity relating to Technical Documentation DOC333ABA56272 supersedes the previous Declaration signed 01-December-2021.

Open the catalog to page 3