Identity
- Trade Name
- ELiS - Reamer II, D8 EUDAMED
- Device Name
- Reusable surgical instruments EUDAMED
- Model / Reference
- 400481 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08592602250270 EUDAMED
- Basic UDI-DI
- 859260200001EG EUDAMED
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Acetabular orthopaedic reamer
ELiS - Reamer II, D8 by BEZNOSKA, s.r.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Acetabular orthopaedic reamer.
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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 | 859260200001EG | Class I | Active |
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Manufacturer
- Manufacturer
- BEZNOSKA, s.r.o.
- EUDAMED SRN
- CZ-MF-000000543
Sources (1)
- EUDAMED 17952ace-934a-48dc-936d-948bdb2fc862 61 fields · synced Jun 19, 2026