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Silicone Scar Sheet

by Zhejiang Ailebao Medical Technology CO., LTD. China EUDAMED

Ref N/AModel Type 200 (Roll) /Type 600 (Sheet)

EMDN M04010203

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697521811SiliconeXG Basic UDI-DIDate20 Sep 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Silicone Scar Sheet
Model / Reference
Type 200 (Roll) /Type 600 (Sheet), N/A
Primary DI / UDI-DI
16975218116014
Basic UDI-DI
697521811SiliconeXG
EMDN Code
M04010203 Fixation silicone dressings
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000027699
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Zhejiang Ailebao Medical Technology CO., LTD.

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 e6b2de3c-438a-40f3-a3a0-261fe69421e3 61 fields · synced 22 Oct 2026