Medical Device Division · registration 180149ActiveTerumo Cardiovascular Systems
Hong KongHeart-Lung Bypass UnitsClass IIITerumo Cardiovascular Systems Corp.
Official record identity
- MDACS listing number
- 180149
- Model name
- Advanced Perfusion System 1 (5773, 5785, 5791, 5793, 6382, 16426, 131115, 144207, 144215, 144223, 145980, 146819, 149876, 150826, 164267, 164268, 164278, 195215, 195240, 195274, 217390, 801016, 801093, 801238, 801327, 801407, 801441, 801550, 801558, 801763, 801764, 802018, 802089, 802110, 802111, 802112, 802113, 802114, 802558, 803479, 803480, 803730, 803739, 803740, 804085, 804372, 804981, 804982, 806455, 814474, 814475, 815453, 816261, 816300, 816370, 816477, 816483, 816489, 816570, 816571, 816572, 816620, 822763, 16553301, 16553401)
- Registration date
- October 22, 2025
- Expiry date
- June 11, 2028
- Source update date
- October 23, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Terumo China (Hong Kong) Limited
- Manufacturer
- Terumo Cardiovascular Systems Corp.
Official description
Heart-Lung Bypass Units
Additional source fields
- AMD nomenclature code
- 11969
- 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
- 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.