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Wound Contact Layer

by Shanghai ISO Medical Products Co., Ltd. EUDAMED

Active European Union

Ref SWCL05750110

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06937935304153 Basic UDI-DIDate30 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Wound Contact Layer
Model / Reference
SWCL05750110
Primary DI / UDI-DI
06937935304153, 56937935304158, 36937935304154
Basic UDI-DI
B-06937935304153, B-56937935304158, B-36937935304154
EMDN Code
M04040702 Silicone dressings, combined with other substances
Device Class
Class IIb
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000002905
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shanghai Iso Medical Products Co., Ltd.

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Properties

Show properties
  • Sterile
Other properties (10)
  • Implantable: No
  • 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