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Vite Corticale Ø5mm L140mm Hap St
EUDAMEDClass IIb (EU MDR)
Ref 5000534HModel ViteRef 5000534ST
by Mikai s.p.a.
Identity
- Trade Name
- VITE CORTICALE Ø5MM L140MM HAP ST EUDAMEDVITE CORTICALE Ø5MM L140MM ST EUDAMED
- Device Name
- Acciaio HAP EUDAMEDAcciaio EUDAMED
- Model / Reference
- Vite EUDAMED5000534H EUDAMED5000534ST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055731432479 EUDAMED08056630554576 EUDAMED
- Basic UDI-DI
- 805573143IMPHAP.SCREW.S6A EUDAMED805573143IMP0000SCREW.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 L140mm Hap 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 | 805573143IMPHAP.SCREW.S6A | Class IIb | Active |
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Manufacturer
- Manufacturer
- Mikai s.p.a.
- EUDAMED SRN
- IT-MF-000030732
Sources (3)
- EUDAMED ad199645-2a96-46fb-8032-ebfe9667e6ab 61 fields · synced Aug 3, 2026
- EUDAMED 8134969b-e29e-46d5-830d-45aed75b6921 61 fields · synced Jun 19, 2026
- EUDAMED 315d2cff-e5bf-4851-a63b-2ade923823d7 61 fields · synced Aug 3, 2026