Identity
- Trade Name
- LEONE SPA FDA UDI
- Generic Name
- Orthodontic extraoral headgear FDA UDI
- Device Name
- Extraoral device EUDAMEDSAFETY MODULE LIGHT PULL TRANSPARENT FDA UDI
- Model / Reference
- M0810-01 EUDAMEDFDA UDI
- Description
- SAFETY MODULE LIGHT PULL TRANSPARENT FDA UDI
Identifiers
- Catalog Number
- M0810-01 FDA UDI
- Primary DI / UDI-DI
- 08033707067948 EUDAMEDFDA UDI
- Basic UDI-DI
- 080337070TDI002VH EUDAMED
- FDA Product Code
- DZB FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic extraoral headgear 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 device by Leone S.p.a. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 080337070TDI002VH | 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 fd01ecf9-618a-4d37-a14a-9e2b5a3e20a9 61 fields · synced Jun 18, 2026
- FDA UDI e1bf3daf-153c-4259-bf96-2429d1f83e08 34 fields · synced May 24, 2026