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Perfect Clear Ii

EUDAMED

Class IIa (EU MDR)

Ref 200-331TModel 200-331T PERFECT CLEAR ∥(Tri-Edge) ROTH018

by Osstem Orthodontics Inc.

Identity

Trade Name: PERFECT CLEAR II EUDAMED
Model / Reference: 200-331T PERFECT CLEAR ∥(Tri-Edge) ROTH018 EUDAMED
200-331T EUDAMED

Identifiers

Primary DI / UDI-DI: 08800033423652 EUDAMED
Basic UDI-DI: B-08800033423652 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

Perfect Clear Ii 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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V-Slot — ASTAR ORTHODONTICS INC. · Class IIa

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 1e0bcce7-56d0-47cc-8168-eaf1b6e481e2 61 fields · synced Jun 18, 2026