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Stomadent NEO

by STOMADENT SK s.r.o. 2 variants

Ref NEOModel Dental unit Stomadent

Active European Union

CE MDR 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 Number85820000433DU001JX Basic UDI-DI 85820000433148UDI-DIDate24 Apr 2026RegisteredStatusActive
European UnionCE/MDR Number85820000433DU001JX Basic UDI-DI 85820000433148UDI-DIDate24 Apr 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  • Withdrawn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, CE/MDR Active

Specification

EUDAMED

Device Name
Dental unit Stomadent
Model / Reference
Dental unit Stomadent, NEO
Primary DI / UDI-DI
85820000433148
Basic UDI-DI
85820000433DU001JX, B-85820000433148
EMDN Code
Q0199 Odontology devices - other
Device Class
Class IIa
EU market of registration
Slovakia

Manufacturer details

EUDAMED SRN
SK-MF-000031507

Other devices from STOMADENT SK s.r.o.

Properties

Other properties (13)

  • Sterile: No
  • 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