CollaStat

Device Name

Collagen Hemostatic Agent

Model / Reference

DCF-17012

Primary DI / UDI-DI

08809201012049

Basic UDI-DI

B-08809201012049

EMDN Code

M04050501 Hemostatic dressings based on coagulation factors of animal origin

Device Class

Class III

Market of Registration

Türkiye

EUDAMED SRN

KR-MF-000020019

Authorised representative

Obelis s.a. BE-AR-000000106

• TachoFlow

  Class III

  CE/MDD

• Tissen Universal Applicator – Standard

  Class I

  CE/MDR

• Collabarrier

  Class III

  CE/MDD

• Diaderm Tape

  Class III

  CE/MDR 2024-MDR/QS-055/B Active Valid to Sep 2029 CE/MDR 2024-MDR/TD-055/B Active Valid to Sep 2029

• WA Mem

  Class III

  CE/MDR 2024-MDR/QS-056/C Active Valid to Sep 2029 CE/MDR 2024-MDR/TD-056/C Active Valid to Sep 2029

• Collagen Wound Dressing

  Unclassified

  FDA 510(k) K112580 Active Cleared 1 Jun 2012

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