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Vite Corticale Ø5mm L160mm St
EUDAMEDClass IIb (EU MDR)
Ref 5000535STModel Vite
by Mikai s.p.a.
Identity
- Trade Name
- VITE CORTICALE Ø5MM L160MM ST EUDAMED
- Device Name
- Acciaio EUDAMED
- Model / Reference
- Vite EUDAMED5000535ST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056630554583 EUDAMED
- Basic UDI-DI
- 805573143IMP0000SCREW.SC8 EUDAMED
- EMDN Code
- P09120601 CORTICAL SCREWS 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
Category: Orthopaedic bone screw (non-sliding)
Vite Corticale Ø5mm L160mm St by Mikai s.p.a. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic bone screw (non-sliding).
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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 | 805573143IMP0000SCREW.SC8 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Mikai s.p.a.
- EUDAMED SRN
- IT-MF-000030732
Sources (1)
- EUDAMED a33a8fa2-4cab-4a23-a3fd-2910b9b12570 61 fields · synced Jun 19, 2026