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Retia Medical Systems

by Retia Medical Systems, Inc 5 variants

Ref FG-014-E

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, self-declared

Class I: no certifier involved

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 Number0850044487FG014ELK Basic UDI-DI 00850044487059UDI-DIDate25 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Y Interface Cable - BD TruWave
Model / Reference
FG-014-E
Primary DI / UDI-DI
00850044487059
Basic UDI-DI
0850044487FG014ELK
Direct Marketing DI
00850044487059
EMDN Code
Z12040199 General medicine diagnosis and monitoring instruments - other
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
US-MF-000036445
Authorised representative
Regulatory Quality Management Information Source AREU, S.L.U ES-AR-000002139

Other devices from Retia Medical Systems, Inc

Properties

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