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Uni-port

by Dalim Medical corp. EUDAMED 27 variants

Active European Union

Ref UP03FV2SP-A

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  • Withdrawn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
    SZUTEST Konformitätsbewertungsstelle GmbH 2975
    Issued
    14 Aug 2026
    Expires
    13 Aug 2031

Specification

EUDAMED

Device Name
Sterile Single Use Manual Operated Surgical Retractor
Model / Reference
UP03FV2SP-A
Primary DI / UDI-DI
08806102200735
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