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Hemodialysis Dry Powder

by Ningbo Tianyi Medical Appliance Co., Ltd. FDA registration: China EUDAMED

Ref TY-F-LBD2Model TY-F-B1 EMDN F040201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number694515578001JQ Basic UDI-DIDate24 Sep 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  • Withdrawn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 23 Oct 2026

Device Name
Hemodialysis Dry Powder
Model / Reference
TY-F-B1, TY-F-LBD2
Primary DI / UDI-DI
06945155750216
Basic UDI-DI
694515578001JQ
Direct Marketing DI
06945155750216
EMDN Code
F040201 Dialysis concentrates, basic solutions, powder
Device Class
Class IIb
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
Other properties (13)
  • Sterile: No
  • 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 bf066543-b0f6-46bf-8dfe-8d1fab8f9cb2 61 fields · synced 23 Oct 2026