Medical Device Division · registration 240259ActiveSenoRx
Hong KongVacuum-Assisted Biopsy UnitsClass IISenoRx Inc
Official record identity
- MDACS listing number
- 240259
- Model name
- EnCor Enspire Breast Biopsy System (E4230, DRENCOR, DRENCORMR, ECP0112G, ECP0110G, ECP017G, ECP0112GV, ECP0110GV, ECP017GV, ECPMR0110G, ECPMR0110GBT, ECPMR017G, ECMRINTLOC, ECMRINTLOC7G, DS4001, DS4002, ECTRACOVER, ECTT, ENCLRINSERT10G, ENCFINSERT10G, SCCAN01, AC4001, FSENCOR01, FSENCORMR, ENCFF02, ENCFFF)
- Registration date
- July 23, 2024
- Expiry date
- July 22, 2029
- Source update date
- August 14, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
Official value: II
Published parties
- Registrant / registration holder
- Becton Dickinson Asia Limited
- Manufacturer
- SenoRx Inc
Official description
Vacuum-Assisted Biopsy Units
Additional source fields
- AMD nomenclature code
- 37399
- Traditional Chinese local responsible person
- 碧迪亞洲有限公司
- Local responsible person phone
- 25758668
- Published manufacturer address
- 1625 West 3rd Street, Tempe, Arizona 85281, USA
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.