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VAIOS® Anatomic Humeral Head 42mm, 3mm Offset
EUDAMEDClass IIb (EU MDR)
Ref 801-42-03
Identity
- Device Name
- VAIOS® Anatomic Humeral Head 42mm, 3mm Offset EUDAMED
- Model / Reference
- 801-42-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05032982029286 EUDAMED
- Basic UDI-DI
- B-05032982029286 EUDAMED
- EMDN Code
- P090104010101 EPIPHYSARY HUMERAL COMPONENTS FOR ANATOMICAL PROSTHESES - HUMERAL HEADS EUDAMED
Classification
- Device Class
- Class IIb 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® Anatomic Humeral Head 42mm, 3mm Offset by JRI Orthopaedics Ltd — Class IIb — 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-05032982029286 | Class IIb | 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 03d6b5ab-6123-4833-84a3-f5607e9cd404 61 fields · synced Aug 4, 2026