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Wire products for fixed orthodontic appliance
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref C7111-36
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 EUDAMEDBETA MEM 21X27 STEEL 16X16 W/HK 36mm UP FDA UDI
- Model / Reference
- C7111-36 EUDAMEDFDA UDI
- Description
- BETA MEM 21X27 STEEL 16X16 W/HK 36mm UP FDA UDI
Identifiers
- Catalog Number
- C7111-36 FDA UDI
- Primary DI / UDI-DI
- 08033707086123 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033707086123 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-08033707086123 | 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 3e49480c-2cf2-4a07-bfee-5a660dd64950 61 fields · synced Jul 29, 2026
- FDA UDI a4b147bf-0b57-4e0d-8cdb-0894589c6544 34 fields · synced May 26, 2026