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Flow Coupler Device

by Synovis Micro Companies Alliance, Inc. (a subsidiary of Baxter International Inc.) 5 variants

Ref GEM2754-FC

Active European Union

CE MDR

Valid until

22 Apr 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

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 NumberMDR 778075 Date24 Sep 2026IssuedStatusActive expires 22 Apr 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 778075 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    24 Sep 2026
    Expires
    22 Apr 2030
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Flow Coupler
Model / Reference
GEM2754-FC
Primary DI / UDI-DI
00844735006551
Basic UDI-DI
478180000000000000001167T
EMDN Code
P07010299 Vascular prostheses, synthetic - other
Device Class
Class IIb
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
  • Implantable

Other properties (12)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: 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