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Silhouette Soft

by Sinclair Pharma US Inc. United States EUDAMED

Ref SMS 102

EMDN H0101010199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05060033041628 Basic UDI-DIDate12 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
SMS 102
Primary DI / UDI-DI
05060033041628, 05060033041949
Basic UDI-DI
B-05060033041628, B-05060033041949
EMDN Code
H0101010199 Monofilament absorbable synthetic sutures - other
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000035849
Authorised representative
Sinclair France SAS FR-AR-000008944

Other devices from Sinclair Pharma US Inc.

See all devices from Sinclair Pharma US Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED 65a92871-69a3-4603-997d-2f480aa63765 61 fields · synced 22 Oct 2026
  • EUDAMED 05060033041949|B-05060033041949 61 fields · synced 19 May 2026