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VAIOS® Bone Screw 4.5mm Thread Diameter Length 35mm
EUDAMEDClass III (EU MDR)
Ref 801-08-35
Identity
- Device Name
- VAIOS® Bone Screw 4.5mm Thread Diameter Length 35mm EUDAMED
- Model / Reference
- 801-08-35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05032982029262 EUDAMED
- Basic UDI-DI
- B-05032982029262 EUDAMED
- EMDN Code
- P09018001 SHOULDER PROSTHESES FIXING SCREWS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Norway EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
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
VAIOS® Bone Screw 4.5mm Thread Diameter Length 35mm by JRI Orthopaedics Ltd — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05032982029262 | Class III | Active |
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Manufacturer
- Manufacturer
- JRI Orthopaedics Ltd
- EUDAMED SRN
- GB-MF-000007529
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 58b739e2-4ad3-4ae7-9d93-e2dbdef0b189 61 fields · synced Jun 19, 2026