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- Déclaration de confirmité UE pour Dia-Body Pouch E
Déclaration de confirmité UE pour Dia-Body Pouch E
Déclaration de confirmité UE pour Dia-Body Pouch E
- The product is classified as a Class I medical device under the EU Medical Device Regulation 2017/745 (EU MDR).
- It is self-certified by the manufacturer without the involvement of a Notified Body.
- The Basic UDI-DI is 8994228UP-BPE1PFU.
- EMDN code: Z12040180, indicating it is a general medicine instrument for diagnosis and monitoring.
- The Dia-Body Pouch E© is intended for single patient use, providing additional fixation support for various body delivery systems.
- It is available in multiple designs and colors, non-sterile, and reusable.
- 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.
- The pouch supports various products including Medtronic Minimed™ 630g, 770g, 780g, Tandem T:slim X2™, Ypsomed Mylife™ YpsoPump®, and SOOIL Diabecare DANA-i, among others.
Catalog excerpts
Document number: ALDBE744101250106 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 E© 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 DOC744DBE91129 supersedes the previous Declaration signed 01-December-2021. Page 1 of 3 Reference of the Declaration: DOC744DBE91129
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Intended Purpose: Kaio-Dia® Dia-Body Pouch E©, 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 E© 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 17-01-2025 version #003 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 DOC744DBE91129 supersedes the previous Declaration signed 01-December-2021.
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