Medical Device Division · registration 190346ActiveLepu Medical Technology
Hong KongGuide WiresClass IVLepu Medical Technology (Beijing) Co., Ltd.
Official record identity
- MDACS listing number
- 190346
- Model name
- Balancium PTCA Guide Wire (GW B185-0, GW B185-0J, GW B185-1, GW B185-1J, GW B185-2, GW B185-2J, GW B185-S0, GW B185-S0J, GW B185-S1, GW B185-S1J, GW B185-S2, GW B185-S2J, GW B300-0, GW B300-0J, GW B300-1, GW B300-1J, GW B300-2, GW B300-2J, GW B300-S0, GW B300-S0J, GW B300-S1, GW B300-S1J, GW B300-S2, GW B300-S2J)
- Registration date
- October 07, 2024
- Expiry date
- October 27, 2029
- Source update date
- July 22, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Pacific Medical (Hong Kong) Company Limited
- Manufacturer
- Lepu Medical Technology (Beijing) Co., Ltd.
Official description
Guide Wires
Additional source fields
- AMD nomenclature code
- 11925
- Local responsible person phone
- 23438009
- Published manufacturer address
- No. 37. Chaoqian Road, Changping District, Beijing 102200, China
- 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.