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Soga

by Shenzhen Soga Technology Co., Ltd.

Ref Aurora-SModel Aurora-S,Aurora-T

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 Number697420315OralU4 Basic UDI-DI 16974203150002UDI-DIDate21 Aug 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  • Withdrawn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
Oral Er:YAG laser therapy system
Model / Reference
Aurora-S, Aurora-T
Primary DI / UDI-DI
16974203150002
Basic UDI-DI
697420315OralU4
Direct Marketing DI
16974203150002
EMDN Code
Q010399 Surgical dental devices - other
Device Class
Class IIb
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000023134
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Shenzhen Soga Technology Co., Ltd.

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: 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