Eu Mdd Eu Md Class 3 On The Market 🇹🇷 Türkiye

GOLD ORTOPEDİ SANAYİ VE TİCARET LİMİTED ŞİRKETİ

Devices (same UDI-DI)
1
Certificates
2
Countries
32
Notified Bodies
2

Basic Information

Primary DI
D-8680941564698CN
Basic UDI-DI Code
B-8680941564698CN
Reference
E.R.70039-10011
Device Types
Single use Sterile
Regulation
Eu Mdd
Classification
Eu Md Class 3
Status
On The Market

Additional Description

It is used as a binder in Total Knee Prosthesis to ensure that patients with suitable body anatomy have a wider range of knee flexion. It has the function of protecting the posterior cruciate ligaments (C-R) or cutting the posterior cruciate ligaments (P-S) and has a hyperflex feature that allows full flexion of  140-150°. Hyperflex insert and insert are identical in design. This inner component is produced from Ultra High Molecular Weight Polyethylene (UHMWPE) material.

CND Nomenclature Codes

Code Description
P09090501 REVISION KNEE PROSTHESES FEMORAL COMPONENTS

Certificates

Type Number
MDD Annex II (excluding section 4) 1984-MDD-16-417
MDD Annex II Section 4 1984-MDD-19-623

Available In Countries

🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇸 Iceland 🇮🇹 Italy 🇱🇮 Liechtenstein 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇪 Sweden 🇸🇮 Slovenia 🇸🇰 Slovakia 🇹🇷 Türkiye 🇬🇧 United Kingdom

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