orthodontic bracket

by Zhejiang Headway Medical Equipment Co., Ltd. 17 variants

Ref H7153

Active European Union

CE MDR

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/MDR	Number6970469413960BS Basic UDI-DI	Date8 Jul 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Withdrawn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/MDR Active

Specification

EUDAMED

Device Name: Orthodontic Metal Bracket
Model / Reference: H7153

Primary DI / UDI-DI: 06979966720021, 06979966720007
Basic UDI-DI: 6970469413960BS, B-06979966720007
EMDN Code: Q010403 Orthodontic brackets and buttons

Device Class: Class IIa
EU market of registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000041591
Authorised representative: Luxus Lebenswelt GmbH DE-AR-000005110

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See all devices from Zhejiang Headway Medical Equipment 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