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Shockwave Medical Inc.

Manufacturer of medical devices registered in the European database in Santa Clara, CA, United States.

Registration number (SRN)US-MF-000012770
Short nameSWMI
RoleManufacturer
StatusActive
CountryUnited States
City95054 Santa Clara, CA
AddressBetsy Ross Drive, 5403 95054 Santa Clara, CA
Registered on2021-09-06

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entrySHOCKWAVE MEDICAL, INC. (US) · FDA 3015053858

Notified body certificates

CertificateStatusExpiryTypeBody
MDR 728473supplemented2027-08-17Quality management systemNB 2797

⚠️ State of the register on 2026-08-20. EUDAMED shows only the current version of a certificate — earlier versions are not published, by the Commission or by anyone. A certificate shown as valid here may have changed since. For a legally binding check, consult EUDAMED directly.

The SRN is the registration number assigned by the European Commission. It has been mandatory since 28 May 2026 for any operator placing a medical device on the Union market. Contact details are published in the official register; we do not reproduce them here.

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