Medical Device Division · registration 130397ActiveLake Region Medical
Hong KongGuide WiresClass IILake Region Medical
Official record identity
- MDACS listing number
- 130397
- Model name
- THRUWAY Guidewires (M001492751, M001492761, M001492771, M001492781, M001492791, M001492801, M001492811, M001492821, M001492831, M001492841, M001492851, M001492861, M001492871, M001492881, M001492891, M001492901, M001492911, M001492921, M001492931, M001492941, M001492951, M001492961, M001492971, M001492981, M001492991)
- Registration date
- November 13, 2023
- Expiry date
- November 13, 2028
- Source update date
- December 20, 2023
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
Official value: II
Published parties
- Registrant / registration holder
- Boston Scientific Hong Kong Limited
- Manufacturer
- Lake Region Medical
Official description
Guide Wires
Additional source fields
- AMD nomenclature code
- 11925
- Local responsible person phone
- 29607100
- Published manufacturer address
- 340 Lake Hazeltine Dr., Chaska, MN 55318, 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.