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KiteLock 4% Sterile Catheter Lock Solution

by SterileCare Inc. Canada EUDAMED

Ref SC001 EMDN C010299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00628451571018 Basic UDI-DIDate26 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
SC001
Primary DI / UDI-DI
00628451571018
Basic UDI-DI
B-00628451571018
EMDN Code
C010299 Central venous catheters - other
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CA-MF-000003960
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Incorporates Medicinal Product
Other properties (9)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No

Sources (1)

  • EUDAMED fc1c8060-9564-4187-aabe-e484709df2b1 61 fields · synced 22 Oct 2026