Medical Device Division · registration 200462ActiveMedtronic
Hong KongDefibrillator/Cardioverter/Pacemakers, ImplantableClass IVMedtronic Inc.
Official record identity
- MDACS listing number
- 200462
- Model name
- Cobalt XT HF Quad CRT-D MRI SureScan (DTPA2QQ, DTPA2Q1), Cobalt XT HF CRT-D MRI SureScan (DTPA2D4, DTPA2D1), Cobalt HF Quad CRT-D MRI SureScan (DTPB2QQ, DTPB2Q1), Cobalt HF CRT-D MRI SureScan (DTPB2D4, DTPB2D1), Crome HF Quad CRT-D MRI SureScan (DTPC2QQ, DTPC2Q1), Crome HF CRT-D MRI SureScan (DTPC2D4, DTPC2D1), Cobalt XT DR MRI SureScan (DDPA2D4, DDPA2D1), Cobalt DR MRI SureScan (DDPB3D4, DDPB3D1), Crome DR MRI SureScan (DDPC3D4, DDPC3D1), Cobalt XT VR MRI SureScan (DVPA2D4, DVPA2D1), Cobalt VR MRI SureScan (DVPB3D4, DVPB3D1), Crome VR MRI SureScan (DVPC3D4, DVPC3D1)
- Registration date
- June 05, 2025
- Expiry date
- December 03, 2030
- Source update date
- June 06, 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
Defibrillator/Cardioverter/Pacemakers, Implantable
Additional source fields
- AMD nomenclature code
- 18504
- 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
- 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.