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RenoSiGel

by T&L Co., Ltd. South Korea EUDAMED

Ref SI14EN02

EMDN M04040701

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88000480TLDOCMDR600NZ Basic UDI-DIDate24 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Silicone Gel Sheet
Model / Reference
SI14EN02
Primary DI / UDI-DI
08800048017501
Basic UDI-DI
88000480TLDOCMDR600NZ
EMDN Code
M04040701 Silicone dressings, non-combined
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000016624
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from T&L Co., Ltd.

See all devices from T&L 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 96b8b186-8a8a-4149-9612-c1dfb40c5432 61 fields · synced 24 Oct 2026