Medical Device Division · registration 210101ActiveBeckman Coulter
Hong KongIVD Test Reagent/Kits, Immunoassay, Anemia Test, ErythropoietinIVD Class BBeckman Coulter, Inc.
Official record identity
- MDACS listing number
- 210101
- Model name
- Access EPO (Reagent Pack) (A16364), Access EPO (Calibrators) (A16365)
- Registration date
- July 03, 2025
- Expiry date
- March 17, 2031
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class B
- Published category
- IVD Test Reagent/Kits, Immunoassay, Anemia Test, Erythropoietin
Official value: B
Published parties
- Registrant / registration holder
- Beckman Coulter Hong Kong Limited
- Manufacturer
- Beckman Coulter, Inc.
Official description
IVD Test Reagent/Kits, Immunoassay, Anemia Test, Erythropoietin
Additional source fields
- AMD nomenclature code
- 19137
- Traditional Chinese local responsible person
- 貝克曼庫爾特香港有限公司
- Local responsible person phone
- 28147431
- Published manufacturer address
- 250 South Kraemer Blvd., Brea, California CA 92821, USA
- Revision number
- b
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.