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Déclaration de conformité UE pour Dia-Body Pouch L

Déclaration de conformité UE pour Dia-Body Pouch L

Déclaration de conformité UE pour Dia-Body Pouch L

Product catalog summary
EU Declaration of Conformity Overview
This document is an EU Declaration of Conformity for the Kaio-Dia® Dia-Body Pouch L©, a non-invasive belt designed as a universal device fixation support for various automated insulin and medication delivery systems. The declaration is issued by CV. Anggrek-Liar, with Anik Susilawatiningsih as the Regulatory Affairs Manager.
Legal and Manufacturing Details
  • 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
Product Specifications
  • Basic UDI-DI: 8994228UP-BPL1B6
  • EMDN Code: Z12040180 - General Medicine Instruments for Diagnosis and Monitoring - Hardware
  • Class: I
  • Classification Rule: Annex VIII, Rule 1
Intended Purpose
The Dia-Body Pouch L© is intended to provide additional fixation support for a variety of automated insulin and medication delivery systems. It is non-sterile, reusable, and intended for single patient use only.
Conformity and Certification
The product conforms to the requirements of the medical devices regulation 2017/745 (EU MDR) and is self-certified as a Class I medical device. The conformity assessment was conducted solely by the manufacturer without a Notified Body.
Supported Products
  • Epipen® and Epipen Jr.®
  • NovoRapid® Flexpen, NovoPen Echo®, and NovoPen® 6
  • Lantus SoloStar®
  • Humalog®
  • Inpen™
Conclusion
The declaration confirms that the Kaio-Dia® Dia-Body Pouch L© complies with all applicable European laws and regulations, ensuring its safety and effectiveness for the intended use.
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Catalog excerpts

Déclaration de conformité UE pour Dia-Body Pouch L-1

EU DECLARATION OF CONFORMITY Document number: ALDBL725101240806 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 L© Non-Invasive Belt Basic UDI-DI: 8994228UP-BPL1B6 Identification number: See Appendix 1 Date: 22 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 DOC725DBL89720 supersedes the previous Declaration signed 01-December-2021.

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Déclaration de conformité UE pour Dia-Body Pouch L-2

Intended Purpose: Kaio-Dia® Dia-Body Pouch L©, 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 L© 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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Déclaration de conformité UE pour Dia-Body Pouch L-3

Appendix 1 - List of Supported Product Date : 22-01-2025 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 DOC725DBL89720 supersedes the previous Declaration signed 01-December-2021. Page 3 of 3 Reference of the Declaration: DOC725DBL89720

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