Medical Device Division · registration 220227ActiveAcutus Medical
Hong KongCatheters, Cardiac, Electrophysiology, MappingClass IVAcutus Medical Inc.
Official record identity
- MDACS listing number
- 220227
- Model name
- SentiCath 3D Imaging and Mapping Catheter (459229)
- Registration date
- August 18, 2022
- Expiry date
- August 18, 2027
- Source update date
- August 03, 2023
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Biotronik Hong Kong Limited
- Manufacturer
- Acutus Medical Inc.
Official description
Catheters, Cardiac, Electrophysiology, Mapping
Additional source fields
- AMD nomenclature code
- 41923
- 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 United States of America
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.