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201-1210-01
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 201-1210-01Model FIXED EXPANDER
by Leone S.p.a.
Identity
- Trade Name
- LEONE SPA FDA UDI
- Generic Name
- Orthodontic retainer FDA UDI
- Device Name
- BMX-MINI PALATAL EXP. DIRECT 10MMX12MM . FDA UDI
- Model / Reference
- FIXED EXPANDER EUDAMED201-1210-01 EUDAMEDFDA UDI
- Description
- BMX-MINI PALATAL EXP. DIRECT 10MMX12MM . FDA UDI
Identifiers
- Catalog Number
- 201-1210-01 FDA UDI
- Primary DI / UDI-DI
- 08033707101321 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
201-1210-01 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 cf03bd59-2d73-4383-b7d2-072b94da1586 61 fields · synced Jul 12, 2026
- FDA UDI 96fbc416-e7bd-4622-988d-ee8ed89d4d86 34 fields · synced May 30, 2026