Medical Device Division · registration 170004ActiveGambro
Hong KongDialyzers, Hemodialysis, Hollow-FiberClass IIIGambro Dialysatoren GmbH
Official record identity
- MDACS listing number
- 170004
- Model name
- Theranova 400 (115578), Theranova 500 (115579), Theranova 400 APAC (955367), Theranova 500 APAC (955368)
- Registration date
- November 01, 2024
- Expiry date
- February 01, 2027
- Source update date
- November 22, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Vantive Healthcare Limited
- Manufacturer
- Gambro Dialysatoren GmbH
Official description
Dialyzers, Hemodialysis, Hollow Fiber
Additional source fields
- AMD nomenclature code
- 11234
- Traditional Chinese local responsible person
- 萬益特醫療用品有限公司
- Local responsible person phone
- 28078500
- Published manufacturer address
- Holger-Crafoord-Strasse 26, Hechingen 72379, Germany
- Revision number
- c
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.