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XP-endo Shaper

by FKG Dentaire Sàrl 7 variants

Ref 99.X00.80.S03.FK

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-07640142438434 Basic UDI-DI 07640142438434UDI-DIDate17 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
99.X00.80.S03.FK
Primary DI / UDI-DI
07640142438434
Basic UDI-DI
B-07640142438434
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000017925
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from FKG Dentaire Sàrl

See all devices from FKG Dentaire Sàrl →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • 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