Medical Device Division · registration 190154ActiveTerumo
Hong KongMonitors, Physiologic, Blood Gas/pH, Bedside, ExtracorporealClass IIITerumo Cardiovascular Systems Corp.
Official record identity
- MDACS listing number
- 190154
- Model name
- CDI Blood Parameter Monitoring System 550 (550AHCT, 550AVHCT, 540)
- Registration date
- March 21, 2024
- Expiry date
- June 04, 2029
- Source update date
- October 10, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
- Published category
- Monitors, Physiologic, Blood Gas/pH, Bedside, Extracorporeal
Official value: III
Published parties
- Registrant / registration holder
- Terumo China (Hong Kong) Limited
- Manufacturer
- Terumo Cardiovascular Systems Corp.
Official description
Monitors, Physiologic, Blood Gas/pH, Bedside, Extracorporeal
Additional source fields
- AMD nomenclature code
- 17680
- Traditional Chinese local responsible person
- 泰爾茂中國(香港)有限公司
- Local responsible person phone
- 28660811/25663393
- Published manufacturer address
- 6200 Jackson Road, Ann Arbor, Michigan, 48103, USA
- Revision number
- a
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.