Medical Device Division · registration 130114ActiveCovidien
Hong KongMonitors, Bedside, ElectroencephalographyClass IIICovidien llc
Official record identity
- MDACS listing number
- 130114
- Model name
- BIS Complete Monitoring System (186-1046), BISx (186-0195-AMS), BISX4 (186-0224-AMS), Flexible Circuit Sensors (186-0106, 186-0200, 186-0212), BIS Patient Interface Cable (186-0107)
- Registration date
- June 14, 2023
- Expiry date
- May 24, 2028
- Source update date
- February 05, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Medtronic Hong Kong Medical Limited
- Manufacturer
- Covidien llc
Official description
Monitors, Physiologic, Electroencephalography, Bedside
Additional source fields
- AMD nomenclature code
- 12602
- Traditional Chinese local responsible person
- 美敦力香港醫療有限公司
- Local responsible person phone
- 29191300
- Published manufacturer address
- 15 Hampshire Street, Mansfield MA 02048, USA
- Revision number
- d
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.