Skl

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

Ref L2

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD	NumberB-06973661910084 Basic UDI-DI 06973661910084UDI-DI	Date25 Mar 2024Registered	StatusActive

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

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name: Ultrasonic scaler
Model / Reference: L2

Primary DI / UDI-DI: 06973661910084
Basic UDI-DI: B-06973661910084, 697366191L22U
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