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Wire and preformed wire products for removable orthodontic appliance
EUDAMEDFDA UDIClass I (EU MDR)
Ref C0585-95
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 EUDAMEDLABIAL ARCHES STANDARD KIT FDA UDI
- Model / Reference
- C0585-95 EUDAMEDFDA UDI
- Description
- LABIAL ARCHES STANDARD KIT FDA UDI
Identifiers
- Catalog Number
- C0585-95 FDA UDI
- Primary DI / UDI-DI
- 08033707002802 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033707002802 EUDAMED
- FDA Product Code
- EHP FDA UDI
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
- GMDN Term
- Orthodontic wire FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 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 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-08033707002802 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Leone S.p.a.
- EUDAMED SRN
- IT-MF-000005986
Sources (2)
- EUDAMED d098af0b-410b-42a2-ae4d-0d5062b5f391 61 fields · synced Sep 18, 2026
- FDA UDI ed6bc2ae-7866-4683-8934-67170905142c 34 fields · synced May 30, 2026