Medical Device Division · registration 210438ActiveEdan
Hong KongIVD Test Reagent/Kits, Clinical Chemistry, Blood Gas/pHIVD Class CEdan Instruments, Inc.
Official record identity
- MDACS listing number
- 210438
- Model name
- 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, )
- Registration date
- January 17, 2022
- Expiry date
- January 17, 2027
- Source update date
- December 20, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class C
- Published category
- IVD Test Reagent/Kits, Clinical Chemistry, Blood Gas/pH
Official value: C
Published parties
- Registrant / registration holder
- Pengbang Medical (HK) Co., Limited
- Manufacturer
- Edan Instruments, Inc.
Official description
IVD Test Reagent/Kits, Clinical Chemistry, Blood Gas/pH
Additional source fields
- AMD nomenclature code
- 17126
- Traditional Chinese local responsible person
- 鵬邦醫療器械（香港）有限公司
- Local responsible person phone
- 66499391
- Published manufacturer address
- #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District, 518122 Shenzhen, People's Republic of China
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.