Identity
- Trade Name
- ELiS - Cannulated countersink II EUDAMED
- Device Name
- Reusable surgical instruments EUDAMED
- Model / Reference
- 400480 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08592602250263 EUDAMED
- Basic UDI-DI
- 859260200001EG EUDAMED
- EMDN Code
- L0916 ORTHOPAEDIC SURGERY BURS AND TIPS, 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: Fluted surgical drill bit, reusable
ELiS - Cannulated countersink II by BEZNOSKA, s.r.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Fluted surgical drill bit, reusable.
- RingLoc® + — Biomet Orthopedics, Inc. · Class I
- DLC Cortical Bone Drill 5.7mmD Implant — IMPLANT DIRECT SYBRON MANUFACTURING LLC · Class II
- MatrixMANDIBLE — Synthes · Class II
- Brasseler — SUNCOAST DENTAL, INC. · Class I
- ROTACYJNE NARZĘDZIA CHIRURGICZNE — ChM spółka z ograniczoną odpowiedzialnością · Class IIa
- ROTACYJNE NARZĘDZIA CHIRURGICZNE — ChM spółka z ograniczoną odpowiedzialnością · Class IIa
- Revision Knee System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class I
- Straight Twist Drill — DENTIS CO. , LTD · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BEZNOSKA, s.r.o.
- EUDAMED SRN
- CZ-MF-000000543
Sources (1)
- EUDAMED 0a6cc473-6f30-431d-ac47-8fc0cbca6f77 61 fields · synced Jun 19, 2026