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Uni-port

by Dalim Medical corp. EUDAMED

Active European Union

Ref UP04FLV2-F

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2975-MED-2622601 Date14 Aug 2026IssuedStatusActive expires 13 Aug 2031

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2975-MED-2622601 Active

    Quality management system EU MDR

    Notified body
    2975
    Issued
    14 Aug 2026
    Expires
    13 Aug 2031

Specification

EUDAMED

Device Name
Sterile Single Use Manual Operated Surgical Retractor
Model / Reference
UP04FLV2-F
Primary DI / UDI-DI
08806102200544
Basic UDI-DI
88061022UP0001BY
EMDN Code
K01020106 Minimally invasive surgery spreaders and retractors, single-use
Device Class
Class IIa
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
KR-MF-000019876
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from Dalim Medical Corp.

  • Uni-port

    Class IIa

  • Eagle-port

    Class IIa

  • Uni-port

    Class IIa

  • Uni-port

    Class IIa

  • Uni-port

    Class IIa

  • Uni-port

    Class IIa

See all devices from Dalim Medical Corp. →

Properties

  • Sterile

Other properties (12)

  • 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