- Catalogs
- SARL Kaio-Dia
- Déclaration de conformité UE pour Dia-Bellyband Mesh
Déclaration de conformité UE pour Dia-Bellyband Mesh
Déclaration de conformité UE pour Dia-Bellyband Mesh
- Product Name: Kaio-Dia® Dia-Belt Mesh Window©
- Basic UDI-DI: 8994228UA-BBZM8022G
- Classification: Class I medical device
- EMDN Code: Z12040180
- Intended Use: Provides additional fixation support for insulin and medication delivery systems, available in pediatric and adult sizes, non-sterile, reusable for single patient use.
- The product complies with the EU Medical Device Regulation 2017/745 (EU MDR).
- Self-certified as a Class I medical device, without the involvement of a Notified Body.
- Technical Documentation Reference: DOC309BBTM76577
- 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 (Indonesia), FR-AR-000037267 (France), NL-AR-000044388 (Netherlands)
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Catalog excerpts
EU DECLARATION OF CONFORMITY Document number: ALBBTM309101220307 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-Belt Mesh Window© Non-Invasive Belt Basic UDI-DI: 8994228UA-BBZM8022G Identification number: See Appendix 1 Date: 07 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 DOC309BBTM76577 supersedes the previous Declaration signed 01-December-2021.
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Intended Purpose: Kaio-Dia® Dia-Belt Mesh Window©, a belt 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 #2) Dia-Belt Mesh Window© 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...
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Appendix 1 - List of Supported Product Date : 07-01-2025 Version #2 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 DOC309BBTM76577 supersedes the previous Declaration signed 01-December-2021. Page 3 of 3 Reference of the Declaration: DOC309BBTM76577
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