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Dental micromotor handpieces for intraoral use

by Saeyang Co., Ltd. 8 variants

Model SDE-ES04

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08809394971192 Basic UDI-DI 08809394971192UDI-DIDate6 Oct 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
Dental micromotor handpieces for intraoral use
Model / Reference
SDE-ES04
Primary DI / UDI-DI
08809394971192
Basic UDI-DI
B-08809394971192
EMDN Code
Z12110101 Dental treatment units
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000034170
Authorised representative
Marathon Italia S.R.L. IT-AR-000027858

Related devices

Category: Dental delivery system

Other devices from Saeyang Co., Ltd.

See all devices from Saeyang Co., Ltd. →

Properties

  • Reusable

Other properties (10)

  • Sterile: No
  • Implantable: 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