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Spex

by Reflow Medical, Inc. 6 variants

Ref SPN35150CEModel WGM, WMC, SPX, SPN, SLP

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number856492005SupportCathKP Basic UDI-DI 00850025525312UDI-DIDate20 May 2024RegisteredStatusActive

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  • Withdrawn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

Model / Reference
WGM, WMC, SPX, SPN, SLP, SPN35150CE
Primary DI / UDI-DI
00850025525312
Basic UDI-DI
856492005SupportCathKP
EMDN Code
C0104020202 Peripheral embolisation catheters and microcatheters
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
US-MF-000017521
Authorised representative
MediMark Europe Sarl. FR-AR-000000182

Other devices from Reflow Medical, Inc.

See all devices from Reflow Medical, 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