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Flow Coupler Device

by Synovis Micro Companies Alliance, Inc. (a subsidiary of Baxter International Inc.)

Ref GEM1003EXT-FC

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number478180000000000000001177V Basic UDI-DI 00844735006582UDI-DIDate9 Jun 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  • Withdrawn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
FLOW COUPLER External Lead
Model / Reference
GEM1003EXT-FC
Primary DI / UDI-DI
00844735006582
Basic UDI-DI
478180000000000000001177V
EMDN Code
C019004 Cardiovascular monitoring systems
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000034162
Authorised representative
Baxter Deutschland GmbH DE-AR-000010308

Other devices from Synovis Micro Companies Alliance, Inc. (a subsidiary of Baxter International Inc.)

See all devices from Synovis Micro Companies Alliance, Inc. (a subsidiary of Baxter International Inc.) →

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