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-8680941527204A8
- Basic UDI-DI Code
- B-8680941527204A8
- Reference
- E.70539-04005
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- GOLD ORTOPEDİ SANAYİ VE TİCARET LİMİTED ŞİRKETİ
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 120 °. 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 |
|---|---|
| P0909030101 | BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 1984-MDD-16-417 | Kiwa Belgelendirme Hizmetleri A.Ş. | Expired |
| MDD Annex II Section 4 | 1984-MDD-19-623 | Kiwa Belgelendirme Hizmetleri A.Ş. | Expired |
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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