Identity
- Trade Name
- Xenium EUDAMED
- Device Name
- Orthodontic Brackets EUDAMEDOrthodontic Lingual Buttons EUDAMED
- Model / Reference
- TS12-55-345H EUDAMED4340-08R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941673551861 EUDAMED
- Basic UDI-DI
- 69416735BRK735ND EUDAMED69416735BTN735PQ EUDAMED
- Direct Marketing DI
- 06941673551861 EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Orthodontic tube
Xenium by Astar Orthodontics Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69416735BRK735ND | Class IIa | Active |
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Manufacturer
- Manufacturer
- Astar Orthodontics Inc.
- EUDAMED SRN
- CN-MF-000028647
- Authorised Representative
- BIO CONCEPT, UNIPESSOAL, LDA PT-AR-000021480
Sources (2)
- EUDAMED b7a48f03-2e24-4763-8ae8-91eaab72bb05 61 fields · synced Jun 17, 2026
- EUDAMED 30e2bbae-a3da-4d9b-8e88-306a4c765a71 61 fields · synced Jun 11, 2026