SecurAcath

Model / Reference

SCR-01, 400170

Primary DI / UDI-DI

00865382000273

Basic UDI-DI

08653820002400XXXG5

EMDN Code

C010180,C010299,V9099

Device Class

Class IIb

Market of Registration

Northern Ireland

EUDAMED SRN

US-MF-000009878

Authorised representative

MDSS GmbH DE-AR-000005430

• SecurAcath 12F

  Class II

  CE/MDR 28620239803 Active Valid to Dec 2029 CE/MDD +1authorizations

• SecurAcath 8F

  Class II

  CE/MDD CE/MDR 28620239803 Active Valid to Dec 2029 +1authorizations

• Securacath Universal

  Class II

  FDA 510(k) K092306 Active Cleared 9 Jul 2010

• Securacath Catheter, Model SPK01

  Class II

  FDA 510(k) K082047 Active Cleared 30 Sep 2008

• Modification to Securacath, Model: SPK01

  Class II

  FDA 510(k) K083081 Active Cleared 4 Mar 2009

• SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F

  Class I

  CE/MDD FDA 510(k) K180994 Active Cleared 9 Jul 2019

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