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Extracorporeal Blood Tubing Set

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

Ref TY-NDR-A34, TY-NDR-A18, TY-NDR-A51, TY-NDR-A49, TY-NDR-A44

EMDN B0280

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number694515573200HV Basic UDI-DIDate11 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Extracorporeal Blood Tubing Set
Model / Reference
TY-NDR-A34, TY-NDR-A18, TY-NDR-A51, TY-NDR-A49, TY-NDR-A44
Primary DI / UDI-DI
06945155743706, 06945155743546, 06945155743874, 06945155743850, 06945155743805
Basic UDI-DI
694515573200HV
Direct Marketing DI
06945155743706
06945155743546
06945155743874
06945155743850
06945155743805
EMDN Code
B0280 Blood filters - accessories
Device Class
Class IIa
Market of Registration
Slovenia
Croatia
Belgium
Sweden

Manufacturer details

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

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 (5)

  • EUDAMED d3c2f501-da94-4ad2-bbda-5c776581ce64 61 fields · synced 22 Oct 2026
  • EUDAMED 06945155743546|694515573200HV 61 fields · synced 18 May 2026
  • EUDAMED 06945155743874|694515573200HV 61 fields · synced 18 May 2026
  • EUDAMED 06945155743850|694515573200HV 61 fields · synced 18 May 2026
  • EUDAMED 06945155743805|694515573200HV 61 fields · synced 25 Jul 2026