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Pressure Infusion Bags

by Gcmedica Enterprise Ltd.(Wuxi) China EUDAMED

Ref GC/CE-07Model GC191821 EMDN A088001

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697450061F01SU05066YK Basic UDI-DIDate22 Jul 2022RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Device Name
Pressure Infusion Bags
Model / Reference
GC191821, GC/CE-07
Primary DI / UDI-DI
16974500610742, 16974500610728, 16974500610735
Basic UDI-DI
697450061F01SU05066YK
EMDN Code
A088001 Pressure infusion cuffs, single-use
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000008756
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Gcmedica Enterprise Ltd. (Wuxi)

See all devices from Gcmedica Enterprise Ltd. (Wuxi) →

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 (3)

  • EUDAMED becc55d7-1392-4bcf-a86b-2bf85b7a8399 61 fields · synced 22 Oct 2026
  • EUDAMED 16974500610728|697450061F01SU05066YK 61 fields · synced 17 May 2026
  • EUDAMED 16974500610735|697450061F01SU05066YK 61 fields · synced 19 May 2026