EU DECLARATION OF CONFORMITY Document number: ALDSMS586101240816 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-Style© Medtronic® Simplera™ Non-Invasive Arm Band Basic UDI-DI: 8994228UA-SMS253D8R 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 DOC586DSMS88860 supersedes the previous Declaration signed 01-December-2021.
Open the catalog to page 1Intended 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...
Open the catalog to page 2Appendix 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 DOC586DSMS88860 supersedes the previous Declaration signed 01-December-2021.
Open the catalog to page 3