Déclaration de conformité UE pour Dia-Style Dexcom G6

Product catalog summary

EU Declaration of Conformity Overview

This document is an EU Declaration of Conformity for the Kaio-Dia® Dia-Style© Dexcom G6 Non-Invasive Arm Band, issued by CV. Anggrek-Liar, located in Semarang, Central Java, Indonesia. The declaration is in accordance with the medical device regulation 2017/745 (EU MDR).

Key Details:

Document Number: ALDSDG6509101220315
Basic UDI-DI: 8994228UA-SD253DDK
Single Registration Numbers (SRN): ID-MF-000037819 (Indonesia), FR-AR-000037267 (France), NL-AR-000044388 (Netherlands)
Legal Manufacturer: CV. Anggrek-Liar, Semarang, Indonesia
EU Authorized Representative: Kaio-Dia Europe Sasu, France
Manufacturing Sites: Anggrek-Liar / Kaio-Care, Indonesia and MAF Holding BV, Netherlands

Intended Purpose:

The Kaio-Dia® Dia-Style© arm band is designed as a universal aftermarket accessory to provide additional fixation support for diabetes sensors, specifically the Dexcom G6. It is available in pediatric and adult sizes, non-sterile, reusable, and intended for single patient use only.

Classification and Compliance:

EMDN Code: Z12040180 - General Medicine Instruments for Diagnosis and Monitoring - Hardware
Class: I
Classification Rule: Annex VIII, Rule 1
The product is self-certified as a Class I medical device under Regulation (EU) 2017/745, with conformity based on technical documentation reference DOC509DSDG672128.

Responsibility:

The undersigned, Anik Susilawatiningsih, Regulatory Affairs Manager, assumes full responsibility for ensuring compliance with all applicable European laws and regulations.

Appendix:

Appendix 1 lists the supported product, Dexcom G6, by DexCom, Inc.

Catalog excerpts

Déclaration de conformité UE pour Dia-Style Dexcom G6-1

EU DECLARATION OF CONFORMITY Document number: ALDSDG6509101220315 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 MAF Holding BV Laan van Leeuwesteyn 62 2271 HL Voorburg, Nederland Single Registration Number (SRN) NL-AR-000044388 Declare under our sole responsibility for the universal device fixation support: Kaio-Dia® Dia-Style© Dexcom G6 Non-Invasive Arm Band Basic UDI-DI: 8994228UA-SD253DDK Identification number: See Appendix 1 Date: 13 December 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 DOC509DSDG672128 supersedes the previous Declaration signed 01-December-2021.

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Déclaration de conformité UE pour Dia-Style Dexcom G6-2

Intended Purpose: Kaio-Dia® Dia-Style©, an arm band are independently developed as universal after market accessories used to provide additional fixation support for Diabetes sensor 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-Style© are available in pediatric and adult sizes 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. EMDN code and description: Z12040180 - GENERAL MEDICINE INSTRUMENTS FOR DIAGNOSIS...

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Déclaration de conformité UE pour Dia-Style Dexcom G6-3

Appendix 1 - List of Supported Product Date 13-12-2024 version #3 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 DOC509DSDG672128 supersedes the previous Declaration signed 01-December-2021.

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