← Back to catalogue
Rotacyjne Narzędzia Chirurgiczne
EUDAMEDClass IIa (EU MDR)
Ref 40.6276.210Model ROTARY SURGICAL INSTRUMENTS
Identity
- Device Name
- ROTACYJNE NARZĘDZIA CHIRURGICZNE EUDAMED
- Model / Reference
- ROTARY SURGICAL INSTRUMENTS EUDAMED40.6276.210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05908447227682 EUDAMED
- Basic UDI-DI
- 59084473NL335 EUDAMED
- Direct Marketing DI
- 05908447227682 EUDAMED
- EMDN Code
- L0916 ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Rotacyjne Narzędzia Chirurgiczne by ChM spółka z ograniczoną odpowiedzialnością — Class IIa — 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
- Revision Knee System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class I
- Straight Twist Drill — DENTIS CO. , LTD · Class I
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class I
- gSource — GSOURCE, LLC. · 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 | 59084473NL335 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ChM spółka z ograniczoną odpowiedzialnością
- EUDAMED SRN
- PL-MF-000002121
Sources (1)
- EUDAMED 9dc054d1-f9c9-43cb-9302-9de4756e9121 61 fields · synced Jun 19, 2026