Medical Device Division · registration 230169ActiveAcutus Medical
Hong KongStereotactic Systems, Image-Guided, Cardiac Mapping/AblationClass IIIAcutus Medical Inc.
Official record identity
- MDACS listing number
- 230169
- Model name
- AcQMap High Resolution Imaging and Mapping System (900100)
- Registration date
- May 09, 2023
- Expiry date
- May 09, 2028
- Source update date
- July 10, 2023
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
- Published category
- Stereotactic Systems, Image-Guided, Cardiac Mapping/Ablation
Official value: III
Published parties
- Registrant / registration holder
- Biotronik Hong Kong Limited
- Manufacturer
- Acutus Medical Inc.
Official description
Stereotactic Systems, Image-Guided, Cardiac Mapping/Ablation
Additional source fields
- AMD nomenclature code
- 18607
- 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.