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Zentrum Careset

by Changzhou Shuangma Medical Devices Co., Ltd 2 variants

Ref 1341Model 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)

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69451447002SYQ74 Basic UDI-DI 06945144713413UDI-DIDate13 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

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), 1341
Primary DI / UDI-DI
06945144713413
Basic UDI-DI
69451447002SYQ74
EMDN Code
A03010103 Infusion controllers with flow regulator
Device Class
Class IIa
EU market of registration
Romania

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

  • Sterile
  • Contains Latex

Other properties (11)

  • Implantable: No
  • Reusable: 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