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Surgical Instruments Kits

by B.T.I. Biotechnology Institute, S.l 3 variants

Ref KFXS

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 Number84353898SURGICAL-BOXVW Basic UDI-DI 08435389830979UDI-DIDate14 Sep 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  • Withdrawn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
Surgical Instruments Kits
Model / Reference
KFXS
Primary DI / UDI-DI
08435389830979
Basic UDI-DI
84353898SURGICAL-BOXVW
EMDN Code
L159099 Odontostomatology instruments, reusable - other
Device Class
Class IIa
Medical Purpose
Surgical Instrument Kits intended to support surgical, prosthetic, and regenerative procedures

Manufacturer details

EUDAMED SRN
ES-PR-000001719

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Properties

Other properties (1)

  • Sterile: No