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T-port Replacement Kit with Luer

by Transcutan AB

Ref 1020-1/LModel 1020-1/E

Expiring European Union

CE MDR

Valid until

20 Sep 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV Rheinland LGA Products GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0735011572014QV Basic UDI-DI 07350115720106UDI-DIDate7 Sep 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IZ 2285527-2 Expiring Amended Expires in 323 days

    Technical documentation EU MDR

    Certifier
    TÜV Rheinland LGA Products GmbH 0197
    Issued
    11 Jul 2025
    Expires
    20 Sep 2027
    Reason
    Mnf data change

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
T-port Enteral Replacement Kit with ENFit
Model / Reference
1020-1/E, 1020-1/L
Primary DI / UDI-DI
07350115720106
Basic UDI-DI
0735011572014QV
Direct Marketing DI
07350115720106
EMDN Code
G02020202 Jejunostomy, tubes and sets
Device Class
Class III
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000015798

Other devices from Transcutan AB

Properties

  • Sterile
  • Implantable
  • CMR Substance
  • Administering Medicine

Other properties (9)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No