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A0623-08d
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref A0623-08DModel FIXED EXPANDER
by Leone S.p.a.
Identity
- Trade Name
- LEONE SPA FDA UDI
- Generic Name
- Orthodontic retainer FDA UDI
- Device Name
- EXPANDER FOR LOWER ARCH CAD-CAM 8mm . FDA UDI
- Model / Reference
- FIXED EXPANDER EUDAMEDA0623-08D EUDAMEDFDA UDI
- Description
- EXPANDER FOR LOWER ARCH CAD-CAM 8mm . FDA UDI
Identifiers
- Catalog Number
- A0623-08D FDA UDI
- Primary DI / UDI-DI
- 08033707100171 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
A0623-08d 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 4731e926-f129-42ab-9a88-2154e8655449 61 fields · synced Jul 22, 2026
- FDA UDI f7e395d9-48e3-47f0-ba94-10237c253d3f 34 fields · synced May 29, 2026