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- SARL Kaio-Dia
- Déclaration de conformité UE pour Dia-Body Pouch TP
Déclaration de conformité UE pour Dia-Body Pouch TP
Déclaration de conformité UE pour Dia-Body Pouch TP
- Legal Manufacturer: CV. Anggrek-Liar, Semarang, Central Java, Indonesia
- EU Authorized Representative: Kaio-Dia Europe Sasu, Saint Nicolas, France
- Manufacturing Sites: Anggrek-Liar / Kaio-Care, Semarang, Indonesia and MAF Holding BV, Voorburg, Netherlands
- Basic UDI-DI: 8994228UP-BPTP1K5
- EMDN Code: Z12040180 - General Medicine Instruments for Diagnosis and Monitoring - Hardware
- Class: I
- Classification Rule: Annex VIII, Rule 1
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Catalog excerpts
EU DECLARATION OF CONFORMITY Document number: ALDBTP725101240805 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-Body Pouch TP© Non-Invasive Belt Basic UDI-DI: 8994228UP-BPTP1K5 Identification number: See Appendix 1 Date: 16 January 2025 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 DOC725DBTP89270 supersedes the previous Declaration signed 01-December-2021.
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Intended Purpose: Kaio-Dia® Dia-Body Pouch TP©, 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 #1) Dia-Body Pouch TP© 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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Appendix 1 - List of Supported Product Date : 16-01-2025 Version #1 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 DOC725DBTP89270 supersedes the previous Declaration signed 01-December-2021. Page 3 of 3 Reference of the Declaration: DOC725DBTP89270
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