Medical Device Division · registration 140439ActiveMedtronic
Hong KongLeads, Implantable Cardiac Pacemaker, EndocardialClass IVMedtronic Inc.
Official record identity
- MDACS listing number
- 140439
- Model name
- CapSureFix Novus MRI SureScan (5076) (Lead Lengths: 35 cm, 45 cm, 52 cm, 58 cm, 65 cm, 85 cm) (507635, 507645, 507652, 507658, 507665, 507685)
- Registration date
- February 13, 2025
- Expiry date
- February 12, 2030
- Source update date
- February 27, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Medtronic Hong Kong Medical Limited
- Manufacturer
- Medtronic Inc.
Official description
Leads, Implantable Cardiac Pacemaker, Endocardial
Additional source fields
- AMD nomenclature code
- 12900
- 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 N.E., Minneapolis, MN 55432, 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.