IVD Test Reagent/Kits, Clinical Chemistry, Blood Gas/pH

体外诊断测试试剂/试剂盒、临床化学、血气/pH

Edan Instruments, Inc.·C·Hong Kong MDACS·Registered January 17, 2022

Device overview

Risk class: C
Product code: 17126
State: current
Status: N/A
Product code detail: 17126 IVD Test Reagent/Kits, Clinical Chemistry, Blood Gas/pH

Manufacturer (製造商)

Name: Edan Instruments, Inc.
深圳市理邦精密仪器股份有限公司
Country: China
中国
Address: #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District, 518122 Shenzhen, People's Republic of China
金晖路 #15 号, 坑梓街道, 坪山区, 518122 深圳市, 中华人民共和国

Authorised representative (AR)

Name: Pengbang Medical (HK) Co., Limited
鹏邦医疗器械（香港）有限公司
Phone: 66499391

Regulatory timeline

Registration date: January 17, 2022
Expiry date: January 17, 2027

Product models

Blood Gas and Chemistry Analyzer (i15), Test Cartridge (BG8, BG3, BC4, BG4, BG9, BG10, BG5, BC6, BG9-Lac), Calibrant fluid pack (CP50, CP100), Controls (Blood Gas and Electrolyte Control Level 1, Blood Gas and Electrolyte Control Level 2 Blood Gas and Electrolyte Control Level 3, Hematocrit Control High, Hematocrit Control Low, )

血气和化学分析仪 (i15)、测试盒 (BG8、BG3、BC4、BG4、BG9、BG10、BG5、BC6、BG9-Lac)、校准液包 (CP50、CP100)、对照(血气和电解质控制级别 1、血气和电解质控制级别 2、血气和电解质控制级别 3、血细胞比容控制高、血细胞比容控制低、)

About this record

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Product Info: IVD Test Reagent/Kits, Clinical Chemistry, Blood Gas/pH

產品資訊： 体外诊断测试试剂/试剂盒、临床化学、血气/pH