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Tesio and Chronic Twinline Repair Kit

by Medical Components, Inc. United States(FDA 510(k) applicant) EUDAMED

Ref NITSL-EXT-A EMDN F9080

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number00884908105MQ Basic UDI-DIDate27 May 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  • Withdrawn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 25 Oct 2026

Device Name
Tesio and Chronic Twinline Repair Kits
Model / Reference
NITSL-EXT-A
Primary DI / UDI-DI
00884908165692
Basic UDI-DI
00884908105MQ
EMDN Code
F9080 Dialysis devices - other accessories
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000008230
Authorised representative
MPS Medical Product Service GmbH DE-AR-000005009

Other devices from Medical Components Inc

See all devices from Medical Components Inc →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 00884908165692|00884908105MQ 61 fields · synced 25 Oct 2026