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Gammadis

by Changzhou Shuangma Medical Devices Co., Ltd China EUDAMED

Ref 101124Model A1,A2,A3,A4,A5,A6,IS-G A2 Model 1(latex) ,IS-GA3(Model 3V6),Model 506-1,IS-G A2 Model 1(latex free),Model 1(LATEX FREE,TUBE 170CM)

EMDN A03010103

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69451447002SYQ74 Basic UDI-DIDate29 May 2026RegisteredStatusActive

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
Sterile Infusion Sets for Single Use
Model / Reference
A1, A2, A3, A4, A5, A6, IS-G A2 Model 1(latex), IS-GA3(Model 3V6), Model 506-1, IS-G A2 Model 1(latex free), Model 1(LATEX FREE, TUBE 170CM), 101124
Primary DI / UDI-DI
06945144713536
Basic UDI-DI
69451447002SYQ74
EMDN Code
A03010103 Infusion controllers with flow regulator
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000009732
Authorised representative
Llins Service & Consulting GmbH DE-AR-000009077

Other devices from Changzhou Shuangma Medical Devices Co., Ltd

See all devices from Changzhou Shuangma Medical Devices Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Administering Medicine
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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 8763df88-98d5-4599-8a1b-2feadfaf1880 61 fields · synced 22 Oct 2026