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Orthodontic Bands
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref E9300-295
by Leone S.p.a.
Identity
- Trade Name
- LEONE SPA FDA UDI
- Generic Name
- Orthodontic metal band FDA UDI
- Device Name
- Orthodontic Bands EUDAMEDBANDE ANATOMICHE SMILE I MOL UL 29,5 FDA UDI
- Model / Reference
- E9300-295 EUDAMEDFDA UDI
- Description
- BANDE ANATOMICHE SMILE I MOL UL 29,5 FDA UDI
Identifiers
- Catalog Number
- E9300-295 FDA UDI
- Primary DI / UDI-DI
- 08033707086475 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033707086475 EUDAMED
- FDA Product Code
- ECM FDA UDI
- EMDN Code
- Q010402 ORTHODONTIC BANDS EUDAMED
- GMDN Term
- Orthodontic metal band 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 Bands 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-08033707086475 | 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 f759e27d-5b0d-40d1-bbc6-e4ee46e8f2df 61 fields · synced Aug 4, 2026
- FDA UDI b0fecc15-3676-4a8d-97a9-12514bb462f7 34 fields · synced May 30, 2026