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Perfect Clear Ii
EUDAMEDClass IIa (EU MDR)
Ref 210-551TModel 210-551T PERFECT CLEAR ∥(Tri-Edge) ROTH022
Identity
- Trade Name
- PERFECT CLEAR II EUDAMED
- Model / Reference
- 210-551T PERFECT CLEAR ∥(Tri-Edge) ROTH022 EUDAMED210-551T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800033423713 EUDAMED
- Basic UDI-DI
- B-08800033423713 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
Perfect Clear Ii by Osstem Orthodontics Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800033423713 | Class IIa | Active |
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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 aade6d8f-85e5-4715-ab40-b040ba8b71d4 61 fields · synced Jun 19, 2026