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Vite Trapassante Ø4.5-5mm L200mm F80mm Ti St
EUDAMEDClass IIb (EU MDR)
Ref 5000591FTSTModel Vite
by Mikai s.p.a.
Identity
- Trade Name
- VITE TRAPASSANTE Ø4.5-5MM L200MM F80MM TI ST EUDAMED
- Device Name
- Titanio EUDAMED
- Model / Reference
- Vite EUDAMED5000591FTST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055400670690 EUDAMED
- Basic UDI-DI
- 805573143IMP00TISCREW.SKQ EUDAMED
- EMDN Code
- P09120699 BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER 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 Trapassante Ø4.5-5mm L200mm F80mm Ti 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 | 805573143IMP00TISCREW.SKQ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Mikai s.p.a.
- EUDAMED SRN
- IT-MF-000030732
Sources (1)
- EUDAMED c3c9f90c-3900-4dd6-a100-f5bf80b92de8 61 fields · synced Oct 6, 2026