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Skl

by Guangdong SKL Medical Instrument Co., Ltd. 8 variants

Ref K5

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

Overview

The SKL ultrasonic scaler is a high-quality medical instrument designed for precision and effectiveness in dental cleaning procedures. Developed by Guangdong SKL Medical Instrument Co., Ltd., this device provides reliable and efficient performance, meeting the needs of healthcare professionals and patients alike.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number697366191K52X Basic UDI-DI 06973661910046UDI-DIDate23 Mar 2024RegisteredStatusActive
European UnionCE/MDR Number697366191K52X Basic UDI-DI 06973661910046UDI-DIDate23 Mar 2024RegisteredStatusActive

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  • Withdrawn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

Model / Reference
K5
Primary DI / UDI-DI
06973661910046
Basic UDI-DI
697366191K52X, B-06973661910046
EMDN Code
L159009 Odontostomatology scalers, reusable
Device Class
Class IIa
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000040821
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Guangdong SKL Medical Instrument Co., Ltd.

  • Skl

    Class IIa

  • Skl

    Class IIa

  • Skl

    Class IIa

  • Skl

    Class IIa

  • Skl

    Class IIa

  • Skl

    Class IIa

See all devices from Guangdong SKL Medical Instrument Co., Ltd. →

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