Medical Device Division · registration 190149ActiveTerumo Cardiovascular Systems
Hong KongOxygenators, Extracorporeal MembraneClass IITerumo Cardiovascular Systems Corporation
Official record identity
- MDACS listing number
- 190149
- Model name
- Capiox NX19 Oxygenator with Integrated Arterial Filter
- Registration date
- June 05, 2024
- Expiry date
- June 04, 2029
- Source update date
- October 10, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
Official value: II
Published parties
- Registrant / registration holder
- Terumo China (Hong Kong) Limited
- Manufacturer
- Terumo Cardiovascular Systems Corporation
Official description
Oxygenators, Extracorporeal Membrane
Additional source fields
- AMD nomenclature code
- 17643
- 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
- 125 Blue Ball Rd, Elkton, Maryland, 21921, 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.