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Silk

by Boz Tibbi Malzeme San. Ve Tic. A.S. 316 variants

Ref SB1613

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08680471008464 Basic UDI-DI 08680471008464UDI-DIDate27 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Türkiye
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

  • Türkiye

Specification

EUDAMED

Model / Reference
SB1613
Primary DI / UDI-DI
08680471008464
Basic UDI-DI
B-08680471008464
EMDN Code
H010202020301 Silk with needle
Device Class
Class III
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000025046

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Properties

  • Sterile
  • Implantable

Other properties (9)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No