Identity
- Trade Name
- Aso EUDAMED
- Device Name
- Orthodontic Brackets EUDAMED
- Model / Reference
- 1111-014Hm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941673524889 EUDAMED
- Basic UDI-DI
- 69416735BRK735ND EUDAMED
- Direct Marketing DI
- 06941673524889 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
Aso is a highly advanced orthodontic bracket device designed for optimal alignment and oral health. This medical device meets strict regulatory standards, ensuring the highest level of sterility and safety. With its intuitive user interface and precision-engineered components, Aso provides unparalleled patient outcomes.
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Also classified as Orthodontic tube.
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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 (1)
- EUDAMED 9f55d13b-19a5-4df0-97b7-e50669a76abb 61 fields · synced Jun 27, 2026