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Siemens Healthcare Diagnostics Inc.

Manufacturer of medical devices registered in the European database in Newark, United States.

Registration number (SRN)US-MF-000016336
RoleManufacturer
StatusActive
CountryUnited States
CityDE 19714 Newark
AddressGBC Drive, 500 DE 19714 Newark
Registered on2021-11-10

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entrySiemens Healthcare Diagnostics Inc. (US) · FDA 2432235

Notified body certificates

CertificateStatusExpiryTypeBody
HX 7091841-1supplementedexpires 2026-10-26 — 11 daysQuality management systemNB 0197
HX 7091841-1reissuedexpires 2027-03-07 — 143 daysQuality management systemNB 0197

⚠️ 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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