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Orthodontic tube for activator for extraoral facebow
EUDAMEDFDA UDIClass I (EU MDR)
Ref X0013
by Leone S.p.a.
Identity
- Trade Name
- LEONE SPA FDA UDI
- Generic Name
- Orthodontic tube FDA UDI
- Device Name
- Orthodontic tube for activator for extraoral facebow EUDAMEDPREF.WIRE W/LASER WELDED TUBE 45 FDA UDI
- Model / Reference
- X0013 EUDAMEDFDA UDI
- Description
- PREF.WIRE W/LASER WELDED TUBE 45 FDA UDI
Identifiers
- Catalog Number
- X0013 FDA UDI
- Primary DI / UDI-DI
- 08033707075509 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033707075509 EUDAMED
- FDA Product Code
- DZD FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic tube FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.5410 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Orthodontic tube for activator for extraoral facebow by Leone S.p.a. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08033707075509 | 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 8e99f3e8-e3c7-47fc-b5d9-3e4764d9509f 61 fields · synced Jul 12, 2026
- FDA UDI aa3f50d3-7676-4931-b440-2911cd3d426c 34 fields · synced May 30, 2026