Identity
- Device Name
- VAIOS® Reverse Dome 0mm EUDAMED
- Model / Reference
- 803-03-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05032982035881 EUDAMED
- Basic UDI-DI
- B-05032982035881 EUDAMED
- EMDN Code
- P09010303 GLENOSPHERES 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® Reverse Dome 0mm 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-05032982035881 | 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 6c9944d4-42a8-4bd7-b51a-13452f411889 61 fields · synced Jul 10, 2026