Medical Device Division · registration 230272ActiveBayer
Hong KongInjectors, Contrast Media, Computed TomographyClass IIIBayer Medical Care Inc.
Official record identity
- MDACS listing number
- 230272
- Model name
- MEDRAD Stellant CT Injection System with Certegra Workstation (SCT 310), MEDRAD Stellant Imaging System Interface (ISI) (ISI 700, ISI 800), Connect.CT Module (Connect.CT), Personalized Patient Protocol Technology (P3T) (MIS P3TC, UFK P3TC, MIS P3TA, UFK P3TA, MIS P3TPA, UFK P3TPA), MEDRAD Stellant Sterile Disposable Syringe (SSS-QFT, SSS-CTP-QFT, SSS-SPK, SSS-CTP-SPK, SDS-CTP-QFT, SDS-CTP-SPK, SDS-TRF-CV, SDS-CTP-SCS), MEDRAD Stellant Low Pressure Connector Tubing with Prime Tube (SSS-LP-60, SSS-LP-60-T), Low Pressure Connector Tubing Integral "T" with Check Valve (LP-96-T-CV), MEDRAD Stellant 250cm Single Patient Disposable (SPD 250), MEDRAD Stellant Multi-Patient Kit (SDS MP1), Certegra Imaging System Interface Module for Certegra Workstation (ISI 900G, ISI 900H, ISI 900S, ISI 900T, ISI 900U)
- Registration date
- November 18, 2024
- Expiry date
- August 24, 2028
- Source update date
- September 17, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Prism Technologies Limited
- Manufacturer
- Bayer Medical Care Inc.
Official description
Injectors, Contrast Media, Computed Tomography
Additional source fields
- AMD nomenclature code
- 17969
- Traditional Chinese local responsible person
- 稜科有限公司
- Local responsible person phone
- 27863233
- Published manufacturer address
- 1 Bayer Drive, Indianola, Pennsylvania, 15051-0780, 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.