Medical Device Division · registration 180445ActiveBiotronik
Hong KongLeads, Implantable Cardiac Pacemaker, EndocardialClass IVBIOTRONIK SE & Co. KG
Official record identity
- MDACS listing number
- 180445
- Model name
- Sentus ProMRI OTW QP L-75/49, Sentus ProMRI OTW QP L-85/49, Sentus ProMRI OTW QP L-95/49, Sentus ProMRI OTW QP S-75/49, Sentus ProMRI OTW QP S-85/49, Sentus ProMRI OTW QP S-95/49
- Registration date
- October 15, 2024
- Expiry date
- November 09, 2028
- Source update date
- November 20, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Biotronik Hong Kong Limited
- Manufacturer
- BIOTRONIK SE & Co. KG
Official description
Leads, Implantable Cardiac Pacemaker, Endocardial
Additional source fields
- AMD nomenclature code
- 12900
- Traditional Chinese local responsible person
- 百多力香港有限公司
- Local responsible person phone
- 31904500
- Published manufacturer address
- Woermannkehre 1, 12359 Berlin, Germany
- 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.