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Wire products for fixed orthodontic appliance
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref C0576-948
by Leone S.p.a.
Identity
- Trade Name
- LEONE SPA FDA UDI
- Generic Name
- Orthodontic wire FDA UDI
- Device Name
- Wire products for fixed orthodontic appliance EUDAMEDREVERSE PALATAL BARS - 48mm FDA UDI
- Model / Reference
- C0576-948 EUDAMEDFDA UDI
- Description
- REVERSE PALATAL BARS - 48mm FDA UDI
Identifiers
- Catalog Number
- C0576-948 FDA UDI
- Primary DI / UDI-DI
- 08033707090137 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033707090137 EUDAMED
- FDA Product Code
- EHP FDA UDI
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
- GMDN Term
- Orthodontic wire FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3285 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Wire products for fixed orthodontic appliance by Leone S.p.a. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08033707090137 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Leone S.p.a.
- EUDAMED SRN
- IT-MF-000005986
Sources (2)
- EUDAMED 0cc119dd-4759-46f8-ae87-40fa93fed7c2 61 fields · synced Jul 25, 2026
- FDA UDI 26299381-fbea-4554-b995-925c1450aeaf 34 fields · synced May 25, 2026