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A0620l911
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref A0620L911Model FIXED EXPANDER
by Leone S.p.a.
Identity
- Trade Name
- LEONE SPA FDA UDI
- Generic Name
- Orthodontic retainer FDA UDI
- Device Name
- PALATAL EXPANSION SCREW 11mm . FDA UDI
- Model / Reference
- FIXED EXPANDER EUDAMEDA0620L911 EUDAMEDFDA UDI
- Description
- PALATAL EXPANSION SCREW 11mm . FDA UDI
Identifiers
- Catalog Number
- A0620L911 FDA UDI
- Primary DI / UDI-DI
- 08033707090748 EUDAMEDFDA UDI
- Basic UDI-DI
- 080337070TDIIA001M03-8J EUDAMED
- FDA Product Code
- DYJ FDA UDIJEX FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic retainer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI872.4565 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
A0620l911 by Leone S.p.a. — Class IIa — 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 | 080337070TDIIA001M03-8J | 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 5f423c3e-4e5d-4543-b820-a8c28a39906d 61 fields · synced Jul 23, 2026
- FDA UDI ce3eb1f8-d9c1-4b07-9cb4-8c857f735ea6 34 fields · synced May 29, 2026