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Infusion sets for single use

by Jiangxi Hongda Medical Equipment Group Ltd. China EUDAMED

Ref B301PNModel B3

EMDN A03010199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69207567GSYQ00039D Basic UDI-DIDate30 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
B3, B301PN
Primary DI / UDI-DI
66920756700275
Basic UDI-DI
69207567GSYQ00039D
EMDN Code
A03010199 Infusion controllers - other
Device Class
Class IIa
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
CN-MF-000006019
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Properties & raw data

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

Sources (1)

  • EUDAMED f250bfb8-94f5-4032-98f0-bbfaf50539ee 61 fields · synced 24 Oct 2026