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SYSMEX CORPORATION

Manufacturer of medical devices registered in the European database in Kobe, Japan.

Registration number (SRN)JP-MF-000014037
Short nameSCORP
RoleManufacturer
StatusActive
CountryJapan
City651-2271 Kobe
Address4-4-4 Takatsukadai, Nishi-ku, 651-2271 Kobe
Registered on2021-10-05

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entrySYSMEX CORPORATION (JP) · FDA 3010421384

Notified body certificates

CertificateStatusExpiryTypeBody
V13 110368 0003supplemented2031-06-03Quality management systemNB 0123

⚠️ 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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