Medical Device Division · registration 190058ActiveBIOTRONIK
Hong KongLeads, Implantable Defibrillator/Cardiac PacemakerClass IVBIOTRONIK SE & Co. KG
Official record identity
- MDACS listing number
- 190058
- Model name
- Plexa ProMRI DF-1 SD 65/16, Plexa ProMRI DF-1 SD 65/18, Plexa ProMRI DF-1 SD 75/18, Plexa ProMRI DF-1 S 65, Plexa ProMRI DF-1 S 75, Plexa ProMRI DF-1 S DX 65/15, Plexa ProMRI DF-1 S DX 65/17
- Registration date
- December 08, 2023
- 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 Defibrillator/Cardiac Pacemaker
Additional source fields
- AMD nomenclature code
- 17964
- 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.