210438
C
current
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
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Clinical Chemistry, Blood Gas/pH. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
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
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
17126
Product Code Detail
17126 IVD Test Reagent/Kits, Clinical Chemistry, Blood Gas/pH
State
current
Status
N/A
Manufacturer (製造商)
Edan Instruments, Inc.
深圳市理邦精密仪器股份有限公司
China
中国
#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)
Pengbang Medical (HK) Co., Limited
鹏邦医疗器械（香港）有限公司
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、)