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Vite Corticale Ø5mm L80mm Hap St
EUDAMEDClass IIb (EU MDR)
Ref 5000531HModel ViteRef 5000561STRef 5000531STRef 5000200STRef 5000206ST
by Mikai s.p.a.
Identity
- Trade Name
- VITE CORTICALE Ø5MM L80MM HAP ST EUDAMEDVITE CORTICALE Ø4MM L80MM ST EUDAMEDVITE CORTICALE Ø5MM L80MM ST EUDAMEDVITE CORTICALE Ø2MM L50MM ST EUDAMEDVITE CORTICALE Ø3MM L80MM ST EUDAMED
- Device Name
- Acciaio HAP EUDAMEDAcciaio EUDAMED
- Model / Reference
- Vite EUDAMED5000531H EUDAMED5000561ST EUDAMED5000531ST EUDAMED5000200ST EUDAMED5000206ST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055731432448 EUDAMED08056630554590 EUDAMED08055400672106 EUDAMED08055400671901 EUDAMED08055400671963 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 L80mm 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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- Arthrex® — Arthrex, Inc. · Class II
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- PANGEA — Stryker Corp. · Class II
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 (6)
- EUDAMED 3ec560b0-d958-4e53-8f60-dfdbfafa63c3 61 fields · synced Sep 18, 2026
- EUDAMED 8c611382-9f3a-4737-a185-d526c3887f55 61 fields · synced Jul 9, 2026
- EUDAMED facef83e-a852-464a-a646-4260bb4027be 61 fields · synced Jul 14, 2026
- EUDAMED ee2221f5-84ff-483f-aa9a-f8ba5304c393 61 fields · synced Jul 18, 2026
- EUDAMED b11ea6ec-bf7c-47d0-a4a4-23ee6dc4f259 61 fields · synced Jul 27, 2026
- EUDAMED 7e65c901-39c4-4e71-bac4-1b971066fc7e 61 fields · synced Sep 18, 2026