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by Zhangjiagang Shengang Medical Products Co., Ltd. 17 variants

Ref SG1027Model FC-I-500,FC-I-1000

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69382140107-FCUU Basic UDI-DI 06938214010161UDI-DIDate20 Sep 2025RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device Name
Feeding Container
Model / Reference
FC-I-500, FC-I-1000, SG1027
Primary DI / UDI-DI
06938214010161
Basic UDI-DI
69382140107-FCUU
EMDN Code
A080101 Enteral feeding bags and containers (including those via pump), single-use
Device Class
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000011905
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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See all devices from Zhangjiagang Shengang Medical Products Co., Ltd. →

Properties

  • 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