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Wire products for fixed orthodontic appliance
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref C3912V14
by Leone S.p.a.
Identity
- Trade Name
- LEONE SPA FDA UDI
- Generic Name
- Orthodontic archwire FDA UDI
- Device Name
- Wire products for fixed orthodontic appliance EUDAMEDMEMORIA ARCHWIRE F1000 UP 14X25 V BEND FDA UDI
- Model / Reference
- C3912V14 EUDAMEDFDA UDI
- Description
- MEMORIA ARCHWIRE F1000 UP 14X25 V BEND FDA UDI
Identifiers
- Catalog Number
- C3912V14 FDA UDI
- Primary DI / UDI-DI
- 08033707080640 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033707080640 EUDAMED
- FDA Product Code
- DZC FDA UDI
- EMDN Code
- Q010401 ORTHODONTIC FACE BOWS EUDAMED
- GMDN Term
- Orthodontic archwire FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 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-08033707080640 | 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 bfab8346-1303-4a32-a011-fd1fc826b24e 61 fields · synced Sep 17, 2026
- FDA UDI 27fbd823-ba7f-4ecf-a8f1-01b05553babd 34 fields · synced May 30, 2026