OrthoXel DAC

SRN: IE-MF-000000574 · Cube House, Cork Business and Technology Park, Model Farm Road, T12 H966 Cork, Ireland

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Basic UDI-DIs

776

Total Devices

786

On Market

786

Off Market

Certificates

Valid

Expiring < 6mo

Countries

Basic Information

Address: Cube House, Cork Business and Technology Park, Model Farm Road, T12 H966 Cork, Ireland
Email: [email protected]
Phone: +353(0)212429700
Website: https://www.orthoxel.com/

Regulatory Overview

Regulation

Eu Mdd 758

Eu Mdr 18

Classification

Eu Md Class 2b 643

Eu Md Class 1 98

Eu Md Class 2a 35

Device Types

Certificate Health

Total

Valid

Expiring < 6mo

Expired / Withdrawn

Certificates by Expiry Year

Type	Number	Notified Body	Legislation	Issue Date	Expiry Date	Status
MDD Annex II (excluding section 4)	684866	BSI Group The Netherlands B.V.			Sep 10, 2022
MDD Annex II (excluding section 4)	CE 684866	BSI Group The Netherlands B.V.			Sep 10, 2022

Market Presence

Devices from this manufacturer are available in 1 country across Europe.

🇮🇪 Ireland

Device Portfolio

Name	Regulation	Classification	Market Status	Certificates
"Orange Ø4.9mm Twist Drill X Length 370mm (Use Ø6.0mm Locking Screw)"	EU MDD	Eu Md Class 2a	On Market	1
3.5mm Hex Short Driver Shaft	EU MDR	Eu Md Class 1	On Market	0
3.5mm Hex Short Driver Shaft	EU MDD	Eu Md Class 1	On Market	0
AO Mount Drill Extension (Length 136.5mm)	EU MDD	Eu Md Class 2a	On Market	1
Apex Femoral Nail GT Right Ø 11.0 x 380mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Antegrade Femoral Endcap 0mm Length	EU MDD	Eu Md Class 2b	On Market	1
Apex Antegrade Femoral Endcap 10mm Length	EU MDD	Eu Md Class 2b	On Market	1
Apex Antegrade Femoral Endcap 15mm length	EU MDD	Eu Md Class 2b	On Market	1
Apex Antegrade Femoral Endcap 20mm length	EU MDD	Eu Md Class 2b	On Market	1
Apex Antegrade Femoral Endcap 5mm Length	EU MDD	Eu Md Class 2b	On Market	1
Apex Antegrade Femoral Locking Endcap 0mm Length	EU MDD	Eu Md Class 2b	On Market	1
Apex Endcap Tibial/Retrograde 10mm Length	EU MDD	Eu Md Class 2b	On Market	1
Apex Endcap Tibial/Retrograde 15mm Length	EU MDD	Eu Md Class 2b	On Market	1
Apex Endcap Tibial/Retrograde 20mm Length	EU MDD	Eu Md Class 2b	On Market	1
Apex Endcap Tibial/Retrograde 5mm Length	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 10.0 x 240mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 10.0 x 260mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 10.0 x 280mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 10.0 x 300mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 10.0 x 320mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 10.0 x 340mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 10.0 x 360mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 10.0 x 380mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 10.0 x 400mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 10.0 x 420mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 10.0 x 440mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 10.0 x 460mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 10.0 x 480mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.0 x 240mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.0 x 260mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.0 x 280mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.0 x 300mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.0 x 320mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.0 x 340mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.0 x 360mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.0 x 380mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.0 x 400mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.0 x 420mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.0 x 440mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.0 x 460mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.0 x 480mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.5 x 240mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.5 x 260mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.5 x 280mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.5 x 300mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.5 x 320mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.5 x 340mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.5 x 360mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.5 x 380mm	EU MDD	Eu Md Class 2b	On Market	1
Apex Femoral Nail GT Left Ø 11.5 x 400mm	EU MDD	Eu Md Class 2b	On Market	1

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