← Back to catalogue

Majesty-Slm

EUDAMED

Class IIa (EU MDR)

Ref 137-301Model 137-301 SLM MBT 022 3*0 H3

by Osstem Orthodontics Inc.

Identity

Trade Name: MAJESTY-SLM EUDAMED
Model / Reference: 137-301 SLM MBT 022 3*0 H3 EUDAMED
137-301 EUDAMED

Identifiers

Primary DI / UDI-DI: 08800033432098 EUDAMED
Basic UDI-DI: B-08800033432098 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-Slm by Osstem Orthodontics Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic tube.

Master Series Bracket — American Orthodontics · Class IIa
Metal brackets conventional milled — Bernhard Förster GmbH · Class IIa
Ceramic brackets conventional — Bernhard Förster GmbH · Class IIa
Metal bracket conventional — Bernhard Förster GmbH · Class IIa
Master Series Bracket — American Orthodontics · Class IIa
CASO KIRIONE ROTH .022 7X7 (3-4-5) C/10 — ID-LOGICAL INDUSTRIA E COMERCIO LTDA · Class IIa
Metal Brackets — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
V-Slot — ASTAR ORTHODONTICS INC. · Class IIa

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (1)

EUDAMED a87c3d2c-85e9-44fd-b6bf-c61469f36da1 61 fields · synced Jun 18, 2026