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- Déclaration de conformité UE pour Dia-Band Enfants
Déclaration de conformité UE pour Dia-Band Enfants
Déclaration de conformité UE pour Dia-Band Enfants
- Product Name: Kaio-Dia® Dia-Band Kids©
- Basic UDI-DI: 8994228UA-ABJ123F
- Class: I
- EMDN Code: Z12040180
- Intended Use: Provides additional fixation support for medical devices attached to the skin with adhesive.
- Features: Available in pediatric sizes, various colors, non-sterile, reusable for single patient use.
- The product is self-certified as a Class I medical device under Regulation (EU) 2017/745.
- The conformity assessment was conducted solely by the manufacturer without a Notified Body.
- 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; MAF Holding BV, Voorburg, Netherlands
- Single Registration Numbers (SRN): ID-MF-000037819 (Indonesia), FR-AR-000037267 (France), NL-AR-000044388 (Netherlands)
- Abbot Freestyle Libre 2 & 3
- DexCom G6 & G7
- Insulet Omnipod 5 & Dash
- Medtrum EasySense 7.1
- Menarini GlucoMen Day CGM & Pump
- Medtronic Guardian sensor 3 & 4, The Simplera™
- Sibionics GS1 CGM
Catalog excerpts
EU DECLARATION OF CONFORMITY Document number: ALABJ275101220207 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-Band Kids© Non-Invasive Arm Sleeves Basic UDI-DI: 8994228UA-ABJ123F Identification number: See Appendix 1 Date: 03 December 2024 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 DOC275ABJ33662 supersedes the previous Declaration signed 01-December-2021.
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Intended Purpose: Kaio-Dia® Dia-Band Kids©, arm sleeves are independently developed as universal after market accessories used to provide additional fixation support for a wide variety of medical devices, such as CGM and insulin patch pump, that in their native forms are attached to the skin with an adhesive fixation. (see attachment Appendix 1 – List of Supported Product version #3) Dia-Bands Kids© are available in pediatric sizes and various color design 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....
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Appendix 1 - List of Supported Product Date 03-12-2024 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 DOC275ABJ33662 supersedes the previous Declaration signed 01-December-2021.
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