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Vite Corticale Autoperforante Decalibrata Ø4-3mm L120mm St
EUDAMEDClass IIb (EU MDR)
Ref 5000565STModel Vite
by Mikai s.p.a.
Identity
- Trade Name
- VITE CORTICALE AUTOPERFORANTE DECALIBRATA Ø4-3MM L120MM ST EUDAMED
- Device Name
- Acciaio EUDAMED
- Model / Reference
- Vite EUDAMED5000565ST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055731432134 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
Vite Corticale Autoperforante Decalibrata Ø4-3mm L120mm St by Mikai 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 | 805573143IMP0000SCREW.SC8 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Mikai s.p.a.
- EUDAMED SRN
- IT-MF-000030732
Sources (1)
- EUDAMED 273a939c-763f-497c-8f82-f59882f6ea1b 61 fields · synced Jul 10, 2026