Identity
- Trade Name
- Drill Bit Cannulated 2.0mm EUDAMED
- Device Name
- Sterile Procedure Pack EUDAMED
- Model / Reference
- 101-00011ST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060534894181 EUDAMED
- Basic UDI-DI
- 5060534890008VK EUDAMED
- EMDN Code
- P091303 ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- Non-Specialist Surgical Instruments and Kits, Single-Use EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Joint prosthesis implantation kit, single-use
Drill Bit Cannulated 2.0mm by Clonallon Laboratories Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Joint prosthesis implantation kit, single-use.
- OvertureTi — OVERTURE ORTHOPAEDICS
- Identity Imprint Knee Replacement System — Conformis, Inc. · Class II
- Dekalb Knee Pack — PACKROOM LLC
- IDENTITY IMPRINT — Conformis, Inc. · Class II
- Argo Knotless — Conmed Corporation · Class IIa
- Instruments IIa — Newclip Technics SAS · Class IIa
- Identity Imprint Knee Replacement System — Conformis, Inc. · Class II
- CC-Hook Right — Xiros Limited · Class IIa
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 | 5060534890008VK | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Clonallon Laboratories Ltd
- EUDAMED SRN
- XI-PR-000033753
Sources (1)
- EUDAMED 755d8b13-f41a-4771-87e9-7ca1405e3fa2 61 fields · synced Jun 18, 2026