Manufacturer's Devices - Shockwave Medical Inc.

Address:




5403 Betsy Ross Drive



Santa Clara

California 95054

United States


Authorised Representative/ UK Responsible Person
Name: ICON (LR) Limited
Address:

Concept House 6 Stoneycroft Rise

Chandlers Ford Eastleigh

Hampshire

SO53 3LD

England United Kingdom




Code/Term Type
Ultrasonic lithotripsy system transducer single-useUltrasonic lithotripsy system transducer single-useClass III
Ultrasound thrombolysis system control unitUltrasound thrombolysis system control unitClass IIb
Ultrasound thrombolysis system control unitUltrasonic lithotripsy system transducer single-use Conformity Assessment Certificate ExpiredClass IIb
Ultrasound thrombolysis system control unitUltrasonic lithotripsy system transducer single-use Conformity Assessment Certificate Expired
Ultrasound thrombolysis system control unitUltrasonic lithotripsy system transducer single-use Conformity Assessment Certificate Expired