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CeraFlex

by LifeTech Scientific (Europe) B.V. 42 variants

Ref LE-PFOf-3525

Active European Union

CE MDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08720214005630 Basic UDI-DI 08720214005630UDI-DIDate2 Aug 2023RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
CeraFlex™ PFO Closure System
Model / Reference
LE-PFOf-3525
Primary DI / UDI-DI
08720214005630
Basic UDI-DI
B-08720214005630
EMDN Code
P07040303 Cardiac occluders, foramen ovale and botallo duct
Device Class
Class III
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
NL-MF-000005742

Other devices from LifeTech Scientific (Europe) B.V.

See all devices from LifeTech Scientific (Europe) B.V. →

Properties

  • Sterile
  • Implantable

Other properties (9)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No