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005-2008-12
EUDAMEDClass IIb (EU MDR)
Ref 005-2008-12Model MINI IMPLANT
by Leone S.p.a.
Identity
- Model / Reference
- MINI IMPLANT EUDAMED005-2008-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033707103035 EUDAMED
- Basic UDI-DI
- 080337070TDIIB001M01-8X EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
005-2008-12 by Leone S.p.a. — Class IIb — 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 | 080337070TDIIB001M01-8X | Class IIb | Active |
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Manufacturer
- Manufacturer
- Leone S.p.a.
- EUDAMED SRN
- IT-MF-000005986
Sources (1)
- EUDAMED 31b5102e-be22-4242-bcb3-93bb8339d90c 61 fields · synced Jun 18, 2026