Metal Brackets

by Innovative Material and Devices, Inc 693 variants

Ref 11-112-13HKModel None self-ligating Brackets

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number695706706001-7000K4 Basic UDI-DI 06957067068372UDI-DI	Date26 May 2022Registered	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Withdrawn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

Model / Reference: None self-ligating Brackets, 11-112-13HK

Primary DI / UDI-DI: 06957067068372
Basic UDI-DI: 695706706001-7000K4
EMDN Code: Q010403 Orthodontic brackets and buttons

Device Class: Class IIa
EU market of registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000002280
Authorised representative: Lotus NL B.V. NL-AR-000000121

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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