Orthodontic Brackets

by Hangzhou Westlake Biomaterial Co., Ltd. 66 variants

Model Active Self Ligating Bracket ROTH 0.018"(Hook on 345)

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-06951860605925 Basic UDI-DI 06951860605925UDI-DI	Date11 May 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Withdrawn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: Orthodontic Brackets
Model / Reference: Active Self Ligating Bracket ROTH 0.018"(Hook on 345)

Primary DI / UDI-DI: 06951860605925
Basic UDI-DI: B-06951860605925
EMDN Code: Q010403 Orthodontic brackets and buttons

Device Class: Class IIa
EU market of registration: France

Manufacturer details

EUDAMED SRN: CN-MF-000039344
Authorised representative: Lotus NL B.V. NL-AR-000000121

Other devices from Hangzhou Westlake Biomaterial Co., Ltd.

Orthodontic Wires

Class IIa
Orthodontic Brackets

Class IIa
Orthodontic Wires

Class IIa
Orthodontic Wires

Class IIa
Orthodontic Wires

Class IIa
Orthodontic Wires

Class IIa

See all devices from Hangzhou Westlake Biomaterial Co., Ltd. →

Properties

Other properties (11)

Sterile: No
Implantable: 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