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Vite Talare Fissa Ø11mm Altezza Testa 4-6mm St
EUDAMEDClass IIb (EU MDR)
Ref HOLA11.R06Model Vite
by Mikai s.p.a.
Identity
- Trade Name
- VITE TALARE FISSA Ø11MM ALTEZZA TESTA 4-6MM ST EUDAMED
- Device Name
- Hola EUDAMED
- Model / Reference
- Vite EUDAMEDHOLA11.R06 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056630555610 EUDAMED
- Basic UDI-DI
- 805573143VCA0000TALAR.STF 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 Talare Fissa Ø11mm Altezza Testa 4-6mm 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 | 805573143VCA0000TALAR.STF | Class IIb | Active |
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Manufacturer
- Manufacturer
- Mikai s.p.a.
- EUDAMED SRN
- IT-MF-000030732
Sources (1)
- EUDAMED 96c32137-117e-440f-a631-799967ff56c8 61 fields · synced Jun 20, 2026