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SilkyBarrier®

by Synkotech Biocompatible Materials S.L Spain EUDAMED

Ref SB_SPRAY25Model SB

EMDN M9002

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8437025406SBGV Basic UDI-DIDate25 May 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
SB, SB_SPRAY25
Primary DI / UDI-DI
08437025406616
Basic UDI-DI
8437025406SBGV
Direct Marketing DI
08437025406616
EMDN Code
M9002 Protective devices, lubricants and soothing devices (sprays, gels, fluids and creams)
Device Class
Class I

Manufacturer details

EUDAMED SRN
ES-MF-000031010

Other devices from Synkotech Biocompatible Materials S.L

See all devices from Synkotech Biocompatible Materials S.L →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • 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

Sources (1)

  • EUDAMED ad0404b0-d168-40db-8810-584596494c5a 61 fields · synced 23 Oct 2026