Medical Device Division · registration 150277ActiveBoston Scientific
Hong KongGuide WiresClass IILake Region Medical
Official record identity
- MDACS listing number
- 150277
- Model name
- ZIPwire Hydrophilic Guide Wire (M00146125B1, M00146126B1, M00146151B1, M00146152B1, M00146154B1, M00146155B1, M00146156B1, M00146159B1, M00146161B1, M00146162B1, M00146164B1, M00146165B1, M00146166B1, M00146169B1, M00146231B1, M00146232B1, M00146235B1, M00146236B1, M00146240B1, M00146249B1, M00146254B1, M00146255B1, M00146300B1, M00146301B1, M00146305B1, M00146306B1, M00146308B1, M00146309B1, M00146311B1, M00146312B1, M00146314B1, M00146315B1, M00146316B1, M00146317B1, M00146318B1, M00146319B1, M00146320B1, M00146321B1, M00146322B1, M00146325B1, M00146331B1, M00146350B1, M00146355B1)
- Registration date
- May 22, 2025
- Expiry date
- September 23, 2030
- 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
- c
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.