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Sola

by Shinhung MST Co., Ltd. EUDAMED

Active European Union

Ref NSEW5015SF

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08809457204410 Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

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.

Specification

EUDAMED

Device Name
Sterile dental implant system
Model / Reference
NSEW5015SF
Primary DI / UDI-DI
08809457204410
Basic UDI-DI
B-08809457204410
EMDN Code
P01020101 Dental implants
Device Class
Class IIb
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.

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

Properties

  • Sterile
  • Implantable

Other properties (9)

  • 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