Medical Device Division · registration 240351ActiveBIOTRONIK
Hong KongPacemakers, Cardiac, ImplantableClass IVBIOTRONIK SE & Co. KG
Official record identity
- MDACS listing number
- 240351
- Model name
- Amvia Sky SR-T, Amvia Sky DR-T, Amvia Sky HF-T, Amvia Sky HF-T QP, Amvia Edge SR-T, Amvia Edge DR-T, Amvia Edge HF-T QP
- Registration date
- August 29, 2024
- Expiry date
- August 28, 2029
- Source update date
- October 16, 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
Pacemakers, Cardiac, Implantable
Additional source fields
- AMD nomenclature code
- 12913
- 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
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.