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T-port Enteral Implant Kit with ENFit

by Transcutan AB

Ref 1010-1/EModel 1010-1/L

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0735011572013QT Basic UDI-DI 07350115720090UDI-DIDate1 Sep 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IZ 2285527-1 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

SwedenNetherlandsGermany
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Expiring

EU market availability

Made available in 3 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Germany since 21 Sep 2022
  • Netherlands since 21 Sep 2022
  • Sweden since 21 Sep 2022

Last checked 31 Oct 2026.

Specification

EUDAMED

Device Name
T-port Enteral Implant Kit with Luer
Model / Reference
1010-1/L, 1010-1/E
Primary DI / UDI-DI
07350115720090
Basic UDI-DI
0735011572013QT
Direct Marketing DI
07350115720090
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