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- SARL Kaio-Dia
- Déclaration de conformité UE pour Dia-Body Pouch Basic
Déclaration de conformité UE pour Dia-Body Pouch Basic
Déclaration de conformité UE pour Dia-Body Pouch Basic
- Product Name: Kaio-Dia® Dia-Body Pouch B©
- Basic UDI-DI: 8994228UP-BPB1A8
- Class: I
- EMDN Code: Z12040180
- Intended Use: Provides additional fixation support for various automated insulin and medication delivery systems.
- Design: Available in various designs and colors, non-sterile, reusable for single patient use.
- The product complies with the EU Medical Device Regulation 2017/745 (EU MDR).
- It is self-certified as a Class I medical device, meaning the manufacturer assumes full responsibility for compliance without a Notified Body's involvement.
- Legal Manufacturer: CV. Anggrek-Liar, Semarang, Central Java, Indonesia
- EU Authorized Representative: Kaio-Dia Europe Sasu, France
- Manufacturing Sites: Anggrek-Liar / Kaio-Care, Indonesia and MAF Holding BV, Netherlands
- Single Registration Numbers (SRN): ID-MF-000037819, FR-AR-000037267, NL-AR-000044388
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Catalog excerpts
EU DECLARATION OF CONFORMITY Document number: ALDBB725101240801 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 B© Non-Invasive Belt Basic UDI-DI: 8994228UP-BPB1A8 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 DOC725DBB89188 supersedes the previous Declaration signed 01-December-2021.
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Intended Purpose: Kaio-Dia® Dia-Body Pouch B©, 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 B© 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 AND...
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Appendix 1 - List of Supported Product Date : 15-01-2025 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 DOC725DBB89188 supersedes the previous Declaration signed 01-December-2021. Page 3 of 3 Reference of the Declaration: DOC725DBB89188
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