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- Déclaration de conformité UE pour Dia-Band Night And Day Enfants
Déclaration de conformité UE pour Dia-Band Night And Day Enfants
Déclaration de conformité UE pour Dia-Band Night And Day Enfants
- Product Name: Kaio-Dia® Dia-Band Night & Day Kids©
- Basic UDI-DI: 8994228UA-ABJ12-NDZR
- 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 complies with the EU Medical Device Regulation 2017/745.
- It is self-certified as a Class I medical device, meaning no Notified Body involvement was required.
- The manufacturer assumes full responsibility for compliance with European laws and regulations.
- Legal Manufacturer: CV. Anggrek-Liar, Semarang, Central Java, Indonesia
- EU Authorized Representative: Kaio-Dia Europe Sasu, France
- Manufacturing Sites: Anggrek-Liar / Kaio-Care, Indonesia; MAF Holding BV, Netherlands
- Single Registration Numbers (SRN): ID-MF-000037819 (Indonesia), FR-AR-000037267 (France), NL-AR-000044388 (Netherlands)
- Includes devices from Abbot, DexCom, Insulet, Medtrum, Menarini, Medtronic, and Sibionics.
- Document Number: ALABJ333101220209
- Technical Documentation Reference: DOC333ABJ56227
- Date of Issue: 06 December 2024
- Place of Issue: Semarang, Central Java, Indonesia
Catalog excerpts
EU DECLARATION OF CONFORMITY Document number: ALABJ333101220209 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 Night & Day Kids© Non-Invasive Arm Sleeves Basic UDI-DI: 8994228UA-ABJ12-NDZR Identification number: See Appendix 1 Date: 06 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 DOC333ABJ56227 supersedes the previous Declaration signed 01-December-2021.
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Intended Purpose: Kaio-Dia® Dia-Band Night & Day 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 Night & Day Kids© are available in pediatric and several 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...
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Appendix 1 - List of Supported Product Date 06-12-2024 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 DOC333ABJ56227 supersedes the previous Declaration signed 01-December-2021.
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