Medical Device Division · registration 180192ActiveBiosense Webster
Hong KongCatheters, Cardiac, ElectrophysiologyClass IVBiosense Webster, Inc.
Official record identity
- MDACS listing number
- 180192
- Model name
- Fixed Curve Electrophysiology (EP) Catheters (F5QD252PS, 1085160S, 1085170S, F5ADP282RT, 1085122RT, F5ADPP10RT, 1085182S, 1085185S, 1085186S, 1085189S, F5QL010ST, 1085192S, F5BF010RT, F5QA002RT, F5QA252RT, F5QA005RT, F5QD252RT, F5QD005RT, F5QD010RT, F5QF252RT, F5QF005RT, F5QF010RT, F5QL005RT, F5CQD005RT, F5CQD252RT, F5SQA252RT, F5QF005CT, F5ADP282CT, F5QA005CT, F5QRA005RT, F5QRF005RT, F5QRA252RT, F5QRF252RT, F5QRD010RT, F5CQF005RT, F5CQA005RT, F5CQA252RT, D1085413, D1085414, F5QL252PS, F5QD010PS, F6QG010PS, 1086540S, F6HA002RT, 1086577S, F6HF005RT, 1086259RT, F6OA002RT, F6OF002RT, F6DG252RT, F6DF252RT, F6ADP282RT, 1086599S, F6QRA005RT, F6QRF005RT, F6BRA010RT, F6QRA252RT, F6QRF252RT, F6QRD010RT, F6QRF010RT, F6QRA010RT, F6QF010ST, F6QL010ST, 1086714S, 1086715S, 1086716S, F6QA002RT, F6QA252RT, F6QA005RT, F6QA010RT, F6QD002RT, F6QD252RT, F6QD005RT, F6QD010RT, F6QF002RT, F6QF252RT, F6QF005RT, F6QF010RT, F6QK002RT, F6QL010RT, F6QL005RT, F6HF002RT, F6HF010RT, F6BF010RT, 1086778S, F6DF005RT, F6QF005CT, F6QA005CT, D1086784, F6QG010RT, F6CQA005RT, F6CQF252RT, F6CQF005RT, F6CQF010RT, F6CQA252RT, F65QA005RT)
- Registration date
- March 03, 2023
- Expiry date
- June 21, 2028
- 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.