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Thermoplastic and Thermoforming material
EUDAMEDClass I (EU MDR)
Ref R7354-07
by Leone S.p.a.
Identity
- Device Name
- Thermoplastic and Thermoforming material EUDAMED
- Model / Reference
- R7354-07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033707103097 EUDAMED
- Basic UDI-DI
- 080337070TDI001VF EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Thermoplastic and Thermoforming material by Leone S.p.a. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 080337070TDI001VF | Class I | Active |
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Manufacturer
- Manufacturer
- Leone S.p.a.
- EUDAMED SRN
- IT-MF-000005986
Sources (1)
- EUDAMED 841a567d-738b-47b7-b411-0efaa9066cf2 61 fields · synced Jun 18, 2026