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RenoCare B

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

Ref HD21EN09

EMDN M04040302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800048013978 Basic UDI-DIDate21 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 24 Oct 2026

Device Name
Hydrocolloid Dressing
Model / Reference
HD21EN09
Primary DI / UDI-DI
08800048013978
Basic UDI-DI
B-08800048013978
EMDN Code
M04040302 Hydrocolloid 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 (1)

  • EUDAMED c90130c9-7dff-4c79-a978-4d6d13cad155 61 fields · synced 24 Oct 2026