Medical Device Division · registration 170256ActiveBiosense Webster
Hong KongCatheters, Cardiac, ElectrophysiologyClass IVBiosense Webster, Inc.
Official record identity
- MDACS listing number
- 170256
- Model name
- 7 Fr. Uni-Directional and Bi-Directional Deflectable Tip CS Catheter with Compression Coil (BD710FJ282RTS, BD710DF282RTS, BD710FJ282CT, BD710DF282CT)
- Registration date
- June 09, 2022
- Expiry date
- September 22, 2027
- Source update date
- September 18, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Johnson & Johnson (Hong Kong) Limited
- Manufacturer
- Biosense Webster, Inc.
Official description
Catheters, Cardiac, Electrophysiology
Additional source fields
- AMD nomenclature code
- 18688
- Traditional Chinese local responsible person
- 強生 (香港) 有限公司
- Local responsible person phone
- 27386080
- Published manufacturer address
- 33 Technology Drive, Irvine, California 92618, USA
- 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.