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ELiS - Sphere, DM - Cementless cup (CC), D10
EUDAMEDClass III (EU MDR)
Ref 413177Model ELIS, Type: T
Identity
- Trade Name
- ELiS - Sphere, DM - Cementless cup (CC), D10 EUDAMED
- Device Name
- REPLACEMENT OF PART OF THE UPPER LIMB - Replacement of Trapeziometacarpal Joint EUDAMED
- Model / Reference
- ELIS, Type: T EUDAMED413177 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08592602249458 EUDAMED
- Basic UDI-DI
- 859260207001FZ EUDAMED
- EMDN Code
- P090404 HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
ELiS - Sphere, DM - Cementless cup (CC), D10 by BEZNOSKA, s.r.o. — Class III — 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 | 859260207001FZ | Class III | Active |
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Manufacturer
- Manufacturer
- BEZNOSKA, s.r.o.
- EUDAMED SRN
- CZ-MF-000000543
Sources (1)
- EUDAMED 69407116-cbf3-475e-b1f6-7ed5484a1cbe 61 fields · synced Jul 26, 2026