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PolySafira Button
EUDAMEDClass IIa (EU MDR)
Ref 30.10.211Model BRACKETS AND TUBES
Identity
- Trade Name
- PolySafira Button EUDAMED
- Model / Reference
- BRACKETS AND TUBES EUDAMED30.10.211 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07895742286262 EUDAMED
- Basic UDI-DI
- B-07895742286262 EUDAMED7895742122FU 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
PolySafira Button by Dental Morelli Ltda. — Class IIa — MDR, MDD — 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07895742286262 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07895742286262 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dental Morelli Ltda.
- EUDAMED SRN
- BR-MF-000004812
- Authorised Representative
- Nuno Flores PT-AR-000003118
Sources (2)
- EUDAMED 69052595-60d0-40f4-ac16-1d92f38072e1 61 fields · synced Jul 9, 2026
- EUDAMED a8f33372-bcf3-43c6-b617-2109c07d589b 61 fields · synced May 17, 2026