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Bonding agents for fixed orthodontic appliance
EUDAMEDClass IIa (EU MDR)
Ref F3143-01
by Leone S.p.a.
Identity
- Device Name
- Bonding agents for fixed orthodontic appliance EUDAMED
- Model / Reference
- F3143-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033707043447 EUDAMED
- Basic UDI-DI
- B-08033707043447 EUDAMED
- EMDN Code
- Q01010402 ENAMEL-DENTINAL ETCHING MATERIALS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Bonding agents for fixed orthodontic appliance by Leone S.p.a. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08033707043447 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Leone S.p.a.
- EUDAMED SRN
- IT-MF-000005986
Sources (1)
- EUDAMED a7d28347-408b-4ba6-9b0f-e413283a90b2 61 fields · synced Jun 20, 2026