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Tissen Universal Applicator – Standard

by Dalim Tissen Co., Ltd. South Korea EUDAMED

Ref DTEA-25011 EMDN A13

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880920101DALIMSADH Basic UDI-DIDate15 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
DTEA-25011
Primary DI / UDI-DI
08809201012001
Basic UDI-DI
880920101DALIMSADH
EMDN Code
A13 Applicators for drugs and medical devices not present in other classes
Device Class
Class I
Market of Registration
Cyprus

Manufacturer details

EUDAMED SRN
KR-MF-000020019
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Dalim Tissen Co., Ltd.

See all devices from Dalim Tissen 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 11feff3e-4c9c-40e0-987a-eb255e9664d4 61 fields · synced 23 Oct 2026