Medical Device Division · registration 200186ActiveBiotronik
Hong KongLeads, Implantable Defibrillator/Cardiac PacemakerClass IVBIOTRONIK SE & Co. KG
Official record identity
- MDACS listing number
- 200186
- Model name
- Plexa ProMRI S 65 (402266), Plexa ProMRI S 75 (402267), Plexa ProMRI SD 65/16 (402262), Plexa ProMRI SD 65/18 (402263), Plexa ProMRI SD 75/18 (402264)
- Registration date
- December 11, 2024
- Expiry date
- June 22, 2030
- 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
- b
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.