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Majesty-Slc

EUDAMED

Class IIa (EU MDR)

Ref 116-503Model SLC ROTH 022 5*0 H345 UP

by Osstem Orthodontics Inc.

Identity

Trade Name: MAJESTY-SLC EUDAMED
Model / Reference: SLC ROTH 022 5*0 H345 UP EUDAMED
116-503 EUDAMED

Identifiers

Primary DI / UDI-DI: 08800033427476 EUDAMED
Basic UDI-DI: B-08800033427476 EUDAMED
EMDN Code: Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED

Classification

Device Class: Class IIa EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Orthodontic tube

Majesty-Slc by Osstem Orthodontics Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

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Also classified as Orthodontic tube.

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CASO KIRIONE ROTH .022 7X7 (3-4-5) C/10 — ID-LOGICAL INDUSTRIA E COMERCIO LTDA · Class IIa
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Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer: Osstem Orthodontics Inc.
EUDAMED SRN: KR-MF-000021559
Authorised Representative: AR Experts B.V. NL-AR-000023989

Sources (1)

EUDAMED d21c5c97-a916-4acd-97b6-b35f2537e838 61 fields · synced Jun 17, 2026