Medical Device Division · registration 240027ActiveBoston Scientific
Hong KongMicrospheres, Embolization, BrachytherapyClass IVBoston Scientific Corporation
Official record identity
- MDACS listing number
- 240027
- Model name
- TheraSphere Yttrium-90 Glass Microspheres (M00139551CE0300, M00139551CE0350, M00139551CE0400, M00139551CE0450, M00139551CE0500, M00139551CE0550, M00139551CE0600, M00139551CE0650, M00139551CE0700, M00139551CE0750, M00139551CE0800, M00139551CE0850, M00139551CE0900, M00139551CE0950, M00139551CE1000, M00139551CE1050, M00139551CE1100, M00139551CE1150, M00139551CE1200, M00139551CE1250, M00139551CE1300, M00139551CE1350, M00139551CE1400, M00139551CE1450, M00139551CE1500, M00139551CE1550, M00139551CE1600, M00139551CE1650, M00139551CE1700, M00139551CE1750, M00139551CE1800, M00139551CE1850, M00139551CE1900, M00139551CE1950, M00139551CE2000), TheraSphere Administration Set (M00139553CEA0, M00139553CEA1, M00139554BBR0, M00139554BBR1), TheraSphere Administration Accessory Kit (M00139556CEKIT0)
- Registration date
- February 06, 2024
- Expiry date
- February 06, 2029
- Source update date
- July 09, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Pacific Medical (Hong Kong) Company Limited
- Manufacturer
- Boston Scientific Corporation
Official description
Microspheres, Embolization, Brachytherapy
Additional source fields
- AMD nomenclature code
- 20372
- Local responsible person phone
- 23438009
- Published manufacturer address
- 300 Boston Scientific Way, Marlborough, MA 01752, United States Of America
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.