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NorrDia

by Ningbo Tianyi Medical Appliance Co., Ltd. United States EUDAMED

Ref Aqualine S RCAModel TX-ZY-4

EMDN F020199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06945155744338 Basic UDI-DIDate29 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Extra-corporeal Blood Circuit
Model / Reference
TX-ZY-4, Aqualine S RCA
Primary DI / UDI-DI
06945155744338
Basic UDI-DI
B-06945155744338
EMDN Code
F020199 Arteriovenous dialysis lines for haemodialysis - haemofiltration -haemodiafiltration - other
Device Class
Class IIa
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000029875
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Ningbo Tianyi Medical Appliance CO., Ltd.

See all devices from Ningbo Tianyi Medical Appliance CO., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 816c8275-0c6e-4586-a50f-38d90a5e82fd 61 fields · synced 22 Oct 2026