Medical Device Division · registration 150017ActiveBiocompatibles UK
Hong KongMicrospheres, Embolization, BrachytherapyClass IVBiocompatibles UK Limited
Official record identity
- MDACS listing number
- 150017
- Model name
- TheraSphere Y-90 Glass Microspheres (OTT-SPE-FP-700), TheraSphere Administration Set (OTT-SPE-FP-001, OTT-SPE-FP-226), TheraSphere Administration Accessory Kit (OTT-SPE-FP-617)
- Registration date
- November 18, 2024
- Expiry date
- February 26, 2030
- Source update date
- August 14, 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
- Biocompatibles UK Limited
Official description
Microspheres, Embolization, Brachytherapy
Additional source fields
- AMD nomenclature code
- 20372
- Local responsible person phone
- 23438009
- Published manufacturer address
- Chapman House, Farnham Business Park, Weydon Lane, Farnham, Surrey GU9 8QL, United Kingdom
- Revision number
- h
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.