Skip to content

Silkus

by TI Medical Private Limited EUDAMED

Active European Union

Ref TI/C-BRO/01Model Braided coated Silk suture with needle,Braided coated Silk suture without needle

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number89042482SIL010MD Basic UDI-DIDate18 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2975-MED-2608201 Issued

    Quality management system EU MDR

    Notified body
    Notified body 2975
    Issued
    23 Mar 2026
    Expires
    22 Mar 2031

Specification

EUDAMED

Device Name
Braided coated Silk suture
Model / Reference
Braided coated Silk suture with needle, Braided coated Silk suture without needle, TI/C-BRO/01
Primary DI / UDI-DI
08904248216549
Basic UDI-DI
89042482SIL010MD
EMDN Code
H010202020301 Silk with needle
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
IN-MF-000026561
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from TI Medical Private Limited

See all devices from TI Medical Private Limited →

Properties

Show properties
  • Sterile
  • Implantable
  • Sutures
Other properties (11)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No