Déclaration de confirmité UE pour Dia-Body Pouch Lace

Product catalog summary

EU Declaration of Conformity Overview

This document is an EU Declaration of Conformity for the Kaio-Dia® Dia-Body Pouch Lace©, a non-invasive pouch designed as a universal accessory for automated insulin and medication delivery systems. It is issued by CV. Anggrek-Liar, with Anik Susilawatiningsih as the Regulatory Affairs Manager.

Key Specifications

Product Name: Kaio-Dia® Dia-Body Pouch Lace©
Basic UDI-DI: 8994228UP-BPLC1LTH
Classification: Class I medical device
EMDN Code: Z12040180
Intended Purpose: Provides additional fixation support for various automated insulin and medication delivery systems.

Compliance and Certification

The product complies with the EU Medical Device Regulation 2017/745 (EU MDR).
It is self-certified as a Class I medical device, meaning no Notified Body involvement was required.

Manufacturing and Legal Information

Legal Manufacturer: CV. Anggrek-Liar, Semarang, Central Java, Indonesia
EU Authorized Representative: Kaio-Dia Europe Sasu, France
Manufacturing Sites: Located in Indonesia and the Netherlands

Supported Products

Medtronic Minimed™ 630g, 770g, 780g
Tandem T:slim X2™
Ypsomed Mylife™ YpsoPump®
SOOIL Diabecare DANA-i, Dana Diabecare RS, Dana Diabecare R

Document Details

Document Number: ALDBA445101250106
Reference: DOC445DBA91426
Date of Issue: 17 January 2025
Place of Issue: Semarang, Central Java, Indonesia

Catalog excerpts

Déclaration de confirmité UE pour Dia-Body Pouch Lace-1

Document number: ALDBA445101250106 Following the provisions of the medical device’s regulation 2017/745 (EU MDR). Legal Manufacturer EU Authorized Representatives CV. Anggrek-Liar Jalan Jomblang Barat 666 RT 09 RW 03 Kelurahan Candi, Kecamatan Candisari Semarang 50257 Central Java Single Registration Number (SRN) ID-MF-000037819 Kaio-Dia Europe Sasu 12, rue Bertrand 31480 Lagraulet Saint Nicolas, France 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 Single Registration Number (SRN) NL-AR-000044388 Declare under our sole responsibility for the universal device fixation support: Kaio-Dia® Dia-Body Pouch Lace© Non-Invasive Pouch Basic UDI-DI: Identification number: SIGNATURE: Date: 17 January 2025 Place of Issue : Semarang, Central Java, Indonesia Name : Anik Susilawatiningsih Function : Regulatory Affairs Manager This Declaration of Conformity relating to Technical Documentation DOC445DBA91426 supersedes the previous Declaration signed 01-December-2021. Page 1 of 3 Reference of the Declaration: DOC445DBA91426

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Déclaration de confirmité UE pour Dia-Body Pouch Lace-2

Intended Purpose: Kaio-Dia® Dia-Body Pouch Lace©, a pouch are independently developed as universal after market accessories used to provide additional fixation support for a wide variety of automated insulin and medication on body delivery systems. (see attachment Appendix 1 – List of Supported Product version #3) Dia-Body Pouch Lace© are available in various design and colors 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 confirmité UE pour Dia-Body Pouch Lace-3

Appendix 1 - List of Supported Product Date 17-01-2025 version #003 Place of Issue : Semarang, Central Java, Indonesia Name : Anik Susilawatiningsih Function : Regulatory Affairs Manager This Declaration of Conformity relating to Technical Documentation DOC445DBA91426 supersedes the previous Declaration signed 01-December-2021.

Open the catalog to page 3