Name: Mistral Model: Self-legating Stainless steel brackets
EUDAMEDClass IIa (EU MDR)
Identity
- Device Name
- Name: Mistral Model: Self-legating Stainless steel brackets EUDAMED
- Model / Reference
- Stainless steel self-legating EUDAMEDBMP8R22 EUDAMED
Identifiers
- Primary DI / UDI-DI
- EMICBMP8R221 EUDAMED
- Basic UDI-DI
- ++EMICFAM3C4A1SFZ EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Category: Orthodontic tube
Mistral Model: Self-legating Stainless steel brackets. This device is a self-legating sterile stainless steel bracket designed for medical implantation. It has been evaluated under the standard and meets high standards of quality, safety, and efficacy in various clinical settings. The Mistral model features advanced technology and innovative design to ensure accurate placement and secure integration with surrounding tissue.
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Also classified as Orthodontic tube.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++EMICFAM3C4A1SFZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Micerium S.p.A.
- EUDAMED SRN
- IT-MF-000010187
Sources (1)
- EUDAMED 5dfbe585-4a09-4c61-a796-d6ad27101e2b 61 fields · synced Jul 18, 2026