Medical Device Division · registration 140097ActiveLake Region Medical
Hong KongGuide WiresClass IILake Region Medical
Official record identity
- MDACS listing number
- 140097
- Model name
- ZIPWIRE Hydrophilic Guidewire (Urological) (M006630200B1, M006630201B1, M006630202B1, M006630212B1, M006630213B1, M006630214B1, M006630203B1, M006630204B1, M006630205B1, M006630206B1, M006630215B1, M006630207B1, M006630208B1, M006630209B1, M006630210B1, M006630211B1, M006630216B1, M006630217B1, M006630221B1, M006630222B1, M006630223B1, M006630224B1, M006630225B1, M006630226B1, M006630227B1, M006630228B1)
- Registration date
- April 07, 2024
- Expiry date
- April 06, 2029
- Source update date
- June 25, 2024
- 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 Drive, Chaska, Minnesota 55318, USA
- Revision number
- d
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.