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Orthodontic Tubes
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref F8125-03
by Leone S.p.a.
Identity
- Trade Name
- LEONE SPA FDA UDI
- Generic Name
- Orthodontic tube FDA UDI
- Device Name
- Orthodontic Tubes EUDAMEDDB TUBE MIM CONV 22/51 LEFT FDA UDI
- Model / Reference
- F8125-03 EUDAMEDFDA UDI
- Description
- DB TUBE MIM CONV 22/51 LEFT FDA UDI
Identifiers
- Catalog Number
- F8125-03 FDA UDI
- Primary DI / UDI-DI
- 08033707057154 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033707057154 EUDAMED
- FDA Product Code
- DZD FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic tube 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
Orthodontic Tubes 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-08033707057154 | 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 8e1b5652-4f42-47dc-9d45-9bcc2a2e79f2 61 fields · synced Jun 18, 2026
- FDA UDI 6aac07b3-def9-4e8e-a823-cde7f6d40301 34 fields · synced May 30, 2026