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OmniKit 100

by Omnia S.r.l 3 variants

Ref 30.A1000.00

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805664650TF17KITJG Basic UDI-DI 08056646508211UDI-DIDate6 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
OmniKit
Model / Reference
30.A1000.00
Primary DI / UDI-DI
08056646508211
Basic UDI-DI
805664650TF17KITJG
EMDN Code
V901699 Specialist surgical instruments and kits not included in other classes, single-use - other
Device Class
Class IIa
Medical Purpose
Kit intended to be used for patient protection and prevention of cross contamination during dental procedure.

Manufacturer details

EUDAMED SRN
IT-PR-000007604

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Properties

Other properties (1)

  • Sterile: No