Medical Device Division · registration 190057ActiveBIOTRONIK
Hong KongLeads, Implantable Cardiac Pacemaker, EndocardialClass IVBIOTRONIK SE & Co. KG
Official record identity
- MDACS listing number
- 190057
- Model name
- Solia S 45, Solia S 53, Solia S 60, Solia T 53, Solia T 60
- Registration date
- February 21, 2025
- Expiry date
- February 25, 2029
- Source update date
- April 23, 2026
- 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
- c
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.