Identity
- Trade Name
- Premium Line EUDAMED
- Device Name
- Orthodontic Brackets and Buttons EUDAMED
- Model / Reference
- 480-0150-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D82948001500009E 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
Premium Line by EC Certification Service GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 006f1b84-0a9f-4165-805a-5461569a682e 61 fields · synced Jun 19, 2026