← Back to catalogue
Vite Corticale Autoperforante Ø5mm L200mm F50mm Hap St
EUDAMEDClass IIb (EU MDR)
Ref VA5H200.50Model Vite
by Mikai s.p.a.
Identity
- Trade Name
- VITE CORTICALE AUTOPERFORANTE Ø5MM L200MM F50MM HAP ST EUDAMED
- Device Name
- Acciaio HAP EUDAMED
- Model / Reference
- Vite EUDAMEDVA5H200.50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056630554781 EUDAMED
- Basic UDI-DI
- 805573143IMPHAP.SCREW.S6A 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 Autoperforante Ø5mm L200mm F50mm Hap St by Mikai s.p.a. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
- EVOS — Smith & Nephew, Inc. · Class II
- TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Zavation — ZAVATION · Class II
- AYSAM — Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi · Class IIb
- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mikai s.p.a.
- EUDAMED SRN
- IT-MF-000030732
Sources (2)
- EUDAMED 25db118a-56ef-457f-82f5-683c274391ac 61 fields · synced Oct 7, 2026
- EUDAMED 9a4212c2-b0a1-4aae-8ce6-7192326c7b94 61 fields · synced Jul 16, 2026