Identity
- Trade Name
- Botón lingual SOLDAR BANDA EUDAMED
- Device Name
- Botón lingual EUDAMED
- Model / Reference
- 2163-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18435645910862 EUDAMED
- Basic UDI-DI
- 84356459216UZ EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Botón lingual SOLDAR BANDA by Dm Ceosa — 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 | 84356459216UZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dm Ceosa
- EUDAMED SRN
- ES-MF-000000579
Sources (1)
- EUDAMED 8604d1f0-c8f6-4eea-b96e-0820f7a6fa28 61 fields · synced Jun 17, 2026