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- Déclaration de conformité UE pour Dia-Style Medtronic Guardian Enlite
Déclaration de conformité UE pour Dia-Style Medtronic Guardian Enlite
Déclaration de conformité UE pour Dia-Style Medtronic Guardian Enlite
- Product Name: Kaio-Dia® Dia-Style© Enlite Non-Invasive Arm Band
- Basic UDI-DI: 8994228UA-SE254DDZ
- Intended Purpose: Provides additional fixation support for Enlite Diabetes sensors.
- Sizes Available: Pediatric and adult sizes, non-sterile, reusable for single patient use.
- EMDN Code: Z12040180 - General Medicine Instruments for Diagnosis and Monitoring - Hardware
- Class: I
- Classification Rule: Annex VIII, Rule 1
- 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 and MAF Holding BV, Voorburg, Netherlands
- Single Registration Numbers (SRN): ID-MF-000037819, FR-AR-000037267, NL-AR-000044388
- Name: Anik Susilawatiningsih
- Function: Regulatory Affairs Manager
- Date of Issue: 13 December 2024
- Place of Issue: Semarang, Central Java, Indonesia
Catalog excerpts
EU DECLARATION OF CONFORMITY Document number: ALDSDSE509101220322 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-Style© Enlite Non-Invasive Arm Band Basic UDI-DI: 8994228UA-SE254DDZ Identification number: See Appendix 1 Date: 13 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 DOC509DSE72333 supersedes the previous Declaration signed 01-December-2021.
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Intended Purpose: Kaio-Dia® Dia-Style©, an arm band are independently developed as universal after market accessories used to provide additional fixation support for Enlite Diabetes sensor 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-Style© 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...
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Appendix 1 - List of Supported Product Date 13-12-2024 version #3 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 DOC509DSE72333 supersedes the previous Declaration signed 01-December-2021.
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