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FLEBOGRIF set for venous insufficiency treatment

by Balton Sp. z o.o.

Ref FLE6F60

Active European Union

CE MDR 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number5901297PHLEBOLOGYAL Basic UDI-DI Date3 Jul 2026RegisteredStatusActive
European UnionCE/MDR Number5901297PHLEBOLOGYAL Basic UDI-DI Date3 Jul 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  • Withdrawn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/MDD, CE/MDR Active

Specification

EUDAMED

Device Name
FLEBOGRIF set for venous insufficiency treatment
Set for Venous Insufficiency Treatment Flebogrif
Model / Reference
FLE6F60
Primary DI / UDI-DI
05901297016611, 05901297318968, 05901297243659, 05901297137156
Basic UDI-DI
5901297PHLEBOLOGYAL, B-05901297318968, B-05901297243659, B-05901297137156
EMDN Code
C01901999 Systems for vessel extraction and vein closure - other
Device Class
Class IIa
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000010568

Other devices from Balton Sp. z o.o.

See all devices from Balton Sp. z o.o. →

Properties

  • Sterile
  • Administering Medicine

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No