Medical Device Division · registration 190387ActiveBIOTRONIK
Hong KongMonitors, Physiologic, Electrocardiography, TelemetricClass IVBIOTRONIK SE & Co. KG
Official record identity
- MDACS listing number
- 190387
- Model name
- BIOMONITOR III (436066), BIOMONITOR IIIm (450218), Remote Assistant III (435292)
- Registration date
- September 20, 2024
- Expiry date
- December 05, 2029
- Source update date
- January 06, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
- Published category
- Monitors, Physiologic, Electrocardiography, Telemetric
Official value: IV
Published parties
- Registrant / registration holder
- Biotronik Hong Kong Limited
- Manufacturer
- BIOTRONIK SE & Co. KG
Official description
Monitors, Physiologic, Electrocardiography, Telemetric
Additional source fields
- AMD nomenclature code
- 13988
- 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.