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Mendec Kypho Set Bilateral 10 mm

by Tecres S.p.A.

Ref ASB028A

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 Number80314970703P7 Basic UDI-DI 08031497003771UDI-DIDate5 Mar 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  • Withdrawn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
Mendec Kypho Set Bilateral
Model / Reference
ASB028A
Primary DI / UDI-DI
08031497003771
Basic UDI-DI
80314970703P7
EMDN Code
P099002 Orthopaedic cement preparation and application devices and kits
Device Class
Class IIa
Medical Purpose
The overall intended purpose of Mendec Kypho Set is the creation of a void within vertebral body by a ballon catheter during percutaneous kyphoplasty (PKP) operation.

Manufacturer details

EUDAMED SRN
IT-PR-000027511

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Properties

  • Sterile