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Wire products for fixed orthodontic appliance
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref C3050-18
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 EUDAMEDARCHES EXTRA SPRING HARD 18 SMALL LOWER FDA UDI
- Model / Reference
- C3050-18 EUDAMEDFDA UDI
- Description
- ARCHES EXTRA SPRING HARD 18 SMALL LOWER FDA UDI
Identifiers
- Catalog Number
- C3050-18 FDA UDI
- Primary DI / UDI-DI
- 08033707003083 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033707003083 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-08033707003083 | 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 30f5e33d-a0b4-4dbd-a599-11cab6fb3b38 61 fields · synced Jun 18, 2026
- FDA UDI 3af61f85-3721-4663-af0b-33995c700e92 34 fields · synced May 30, 2026