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RenoFoam A

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

Ref FS14EN01, FS14EN02, FS14EN03, FS14EN05

EMDN M04040602

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800048019765 Basic UDI-DIDate20 Nov 2025RegisteredStatusActive

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

Device Name
Adhesive Foam Dressing
Model / Reference
FS14EN01, FS14EN02, FS14EN03, FS14EN05
Primary DI / UDI-DI
08800048019765, 08800048019789, 08800048019819, 08800048019772
Basic UDI-DI
B-08800048019765, B-08800048019789, B-08800048019819, B-08800048019772
EMDN Code
M04040602 Polyurethane dressings, combined with other substances
Device Class
Class IIb
Market of Registration
Croatia

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
  • 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

Sources (4)

  • EUDAMED 39de5107-a3e9-48e8-8b89-cec3a4bf6f69 61 fields · synced 22 Oct 2026
  • EUDAMED 08800048019789|B-08800048019789 61 fields · synced 18 May 2026
  • EUDAMED 08800048019819|B-08800048019819 61 fields · synced 19 May 2026
  • EUDAMED 08800048019772|B-08800048019772 61 fields · synced 18 Jun 2026