← Back to catalogue
201a2620-12
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 201A2620-12Model FIXED EXPANDER
by Leone S.p.a.
Identity
- Trade Name
- LEONE SPA FDA UDI
- Generic Name
- Orthodontic retainer FDA UDI
- Device Name
- EXPANDER W/TELESCOP. GUIDES 12mm FOR TADS . FDA UDI
- Model / Reference
- FIXED EXPANDER EUDAMED201A2620-12 EUDAMEDFDA UDI
- Description
- EXPANDER W/TELESCOP. GUIDES 12mm FOR TADS . FDA UDI
Identifiers
- Catalog Number
- 201A2620-12 FDA UDI
- Primary DI / UDI-DI
- 08033707100553 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
201a2620-12 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Leone S.p.a.
- EUDAMED SRN
- IT-MF-000005986
Sources (2)
- EUDAMED 662aff23-8f39-419d-afb6-0e6711f2825e 61 fields · synced Jun 19, 2026
- FDA UDI e647fbc4-2948-4a70-bedd-454248911670 34 fields · synced May 30, 2026