Identity
- Trade Name
- Premium Line EUDAMED
- Device Name
- Orthodontic Brackets and Buttons EUDAMED
- Model / Reference
- 661-0311-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D82966103111009F EUDAMED
- Basic UDI-DI
- ++D829001001PBREM EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Premium Line by EC Certification Service GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthodontic tube.
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- V-Slot — ASTAR ORTHODONTICS INC. · Class IIa
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 | ++D829001001PBREM | Class IIa | Active |
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Manufacturer
- Manufacturer
- EC Certification Service GmbH
- EUDAMED SRN
- AT-MF-000006655
Sources (1)
- EUDAMED fa957e55-ecde-44c7-99fc-52df6b5735c0 61 fields · synced Oct 6, 2026