Skip to content

Sola

by Shinhung MST Co., Ltd. 434 variants

Ref 0068/QCO-DM/300-2021

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08809458319748 Basic UDI-DI 08809458319748UDI-DIDate2 Nov 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  • Withdrawn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 Active

Specification

EUDAMED

Device Name
Sterile & non-sterile dental implant system
Model / Reference
0068/QCO-DM/300-2021
Primary DI / UDI-DI
08809458319748
Basic UDI-DI
B-08809458319748
EMDN Code
P01020101 Dental implants
Device Class
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
KR-MF-000008626
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from Shinhung MST Co., Ltd.

  • Sola

    Class IIb

  • Sis

    Class IIa

  • Luna

    Class IIb

  • Sola

    Class IIb

  • Sola

    Class IIb

  • Luna

    Class IIb

See all devices from Shinhung MST Co., Ltd. →

Properties

  • Implantable

Other properties (10)

  • Sterile: No
  • Reusable: 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