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Smart Soft Healthcare

Manufacturer of medical devices registered in the European database in Varna, Bulgaria.

Registration number (SRN)BG-MF-000038728
Short nameSSHC
RoleManufacturer
StatusActive
CountryBulgaria
City9002 Varna
AddressGeneral Kolev, 113 9002 Varna
Registered on2023-11-16

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entrySMART SOFT HEALTHCARE (BG) · FDA 3029900829

Notified body certificates

CertificateStatusExpiryTypeBody
21M00172CRT01withdrawn2029-08-27Quality management systemNB 1912
1984-MDR-00230168valid2029-08-27Quality management systemNB 1984

⚠️ 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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