← Back to catalogue
Wire and preformed wire products for removable orthodontic appliance
EUDAMEDFDA UDIClass I (EU MDR)
Ref C0400-11
by Leone S.p.a.
Identity
- Trade Name
- LEONE SPA FDA UDI
- Generic Name
- Orthodontic wire FDA UDI
- Device Name
- Wire and preformed wire products for removable orthodontic appliance EUDAMEDLEOWIRE SPRING HARD 1,1mm FDA UDI
- Model / Reference
- C0400-11 EUDAMEDFDA UDI
- Description
- LEOWIRE SPRING HARD 1,1mm FDA UDI
Identifiers
- Catalog Number
- C0400-11 FDA UDI
- Primary DI / UDI-DI
- 08033707001966 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033707001966 EUDAMED
- FDA Product Code
- DZC FDA UDI
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
- GMDN Term
- Orthodontic wire FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 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
No
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 and preformed wire products for removable orthodontic appliance by Leone S.p.a. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-08033707001966 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Leone S.p.a.
- EUDAMED SRN
- IT-MF-000005986
Sources (2)
- EUDAMED 27f1bc04-e880-4ddb-a8b9-56431ca88a9d 61 fields · synced Jul 17, 2026
- FDA UDI e8029d62-5552-4536-9ee9-6f158cf5f55d 34 fields · synced May 30, 2026