Medical Device Division · registration 180449ActiveMedtronic
Hong KongStereotactic Systems, Image-Guided, Cardiac Mapping/AblationClass IIMedtronic Inc.
Official record identity
- MDACS listing number
- 180449
- Model name
- CardioInsight Workstation (CIT200), CardioInsight Mapping Vest (CITVST0001S, CITVST0002M CITVST0003L CITVST0004XL)
- Registration date
- January 31, 2024
- Expiry date
- November 09, 2028
- Source update date
- March 04, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
- Published category
- Stereotactic Systems, Image-Guided, Cardiac Mapping/Ablation
Official value: II
Published parties
- Registrant / registration holder
- Medtronic Hong Kong Medical Limited
- Manufacturer
- Medtronic Inc.
Official description
Stereotactic Systems, Image-Guided, Cardiac Mapping/Ablation
Additional source fields
- AMD nomenclature code
- 18607
- Traditional Chinese local responsible person
- 美敦力香港醫療有限公司
- Local responsible person phone
- 29191300
- Published manufacturer address
- 710 Medtronic Parkway, Minneapolis, MN 55432, USA
- Revision number
- b
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.