Medical Device Division · registration 220208ActiveBiosense Webster
Hong KongCatheters, Vascular, GuidingClass IVBiosense Webster, Inc.
Official record identity
- MDACS listing number
- 220208
- Model name
- CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath (D138501, D138502, D138503)
- Registration date
- September 17, 2026
- Expiry date
- July 11, 2032
- 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, Vascular, Guiding
Additional source fields
- AMD nomenclature code
- 17846
- Traditional Chinese local responsible person
- 強生 (香港) 有限公司
- Local responsible person phone
- 27386080
- Published manufacturer address
- 31 Technology Drive, Suit 200, Irvine, California, 92618, USA
- 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.