Identity
- Trade Name
- LEONE SPA FDA UDI
- Generic Name
- Orthodontic face bow FDA UDI
- Device Name
- Extraoral Devices EUDAMEDEXORAL FACEBOW 045 LOOPS SHORT n. 2 FDA UDI
- Model / Reference
- M4835-02 EUDAMEDFDA UDI
- Description
- EXORAL FACEBOW 045 LOOPS SHORT n. 2 FDA UDI
Identifiers
- Catalog Number
- M4835-02 FDA UDI
- Primary DI / UDI-DI
- 08033707068679 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033707068679 EUDAMED
- FDA Product Code
- DZB FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic face bow FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.5500 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
Extraoral Devices by Leone S.p.a. — Class I — 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-08033707068679 | 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 5fae4ad5-cb4f-4d75-8b24-e52d447b55ab 61 fields · synced Jul 11, 2026
- FDA UDI 88a5583e-4c9d-4665-be2e-472b2ad7d829 34 fields · synced May 30, 2026