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Serranator® PTA Serration Balloon Catheter

by Cagent Vascular, Inc. 19 variants

Ref FGS-0629-35080

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number085249500801850492BT Basic UDI-DI 00852495008401UDI-DIDate20 May 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Serranator PTA Serration Balloon Catheter
Model / Reference
FGS-0629-35080
Primary DI / UDI-DI
00852495008401
Basic UDI-DI
085249500801850492BT
EMDN Code
C010402020101 PTA balloon dilatation catheters
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000012243
Authorised representative
mdi Europa GmbH DE-AR-000006218

Other devices from Cagent Vascular

See all devices from Cagent Vascular →

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