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Thermoplastic and Thermoforming material
EUDAMEDFDA UDIClass I (EU MDR)
Ref R7013-07
by Leone S.p.a.
Identity
- Trade Name
- LEONE SPA FDA UDI
- Generic Name
- Orthodontic retainer FDA UDI
- Device Name
- Thermoplastic and Thermoforming material EUDAMEDTHERMOPLAST. PLATE 125x125mm THICK 0,7mm FDA UDI
- Model / Reference
- R7013-07 EUDAMEDFDA UDI
- Description
- THERMOPLAST. PLATE 125x125mm THICK 0,7mm FDA UDI
Identifiers
- Catalog Number
- R7013-07 FDA UDI
- Primary DI / UDI-DI
- 08033707102878 EUDAMEDFDA UDI
- Basic UDI-DI
- 080337070TDI001VF EUDAMED
- FDA Product Code
- DYJ FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic retainer 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
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
Thermoplastic and Thermoforming material by Leone S.p.a. — Class I — 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 | 080337070TDI001VF | 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 29ab2249-6e78-4e30-8e4c-535c14696579 61 fields · synced Jul 10, 2026
- FDA UDI 5abb8178-3ea0-4cd0-a0ae-a5f47bdab8c8 35 fields · synced May 30, 2026