Medical Device Division · registration 230042ActiveAcutus Medical
Hong KongCatheters, Cardiac, Ablation, Radiofrequency, Contact ForceClass IVAcutus Medical Inc.
Official record identity
- MDACS listing number
- 230042
- Model name
- AlCath Force Sensing Ablation Catheter (457611, 457612, 457613, 457614, 457615)
- Registration date
- February 08, 2023
- Expiry date
- February 08, 2028
- Source update date
- July 10, 2023
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
- Published category
- Catheters, Cardiac, Ablation, Radiofrequency, Contact Force
Official value: IV
Published parties
- Registrant / registration holder
- Biotronik Hong Kong Limited
- Manufacturer
- Acutus Medical Inc.
Official description
Catheters, Cardiac, Electrophysiology, Ablation, Radiofrequency, Contact Force
Additional source fields
- AMD nomenclature code
- 34558
- Traditional Chinese local responsible person
- 百多力香港有限公司
- Local responsible person phone
- 31904500
- Published manufacturer address
- 2210 Faraday Avenue, Suite 100, Carlsbad, CA 92008, USA
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.