Eu Mdd
Eu Md Class 2a
On The Market
🇩🇪 Germany
Instruments and Trial Tray for Biotech Sterile Hip Endoprosthesis Systems
Devices (same UDI-DI)
1
Certificates
1
Countries
7
Notified Bodies
1
Basic Information
- Primary DI
- D-4049852HI2CSSK
- Basic UDI-DI Code
- B-4049852HI2CSSK
- Reference
- 4049852HI2CS
- Device Types
-
Sterilization
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Biotech GmbH
Additional Description
Trial elements and instrument set accessories for the surgical implantation/removal and revision of the "Biotech Sterile Hip Endoprosthesis Systems". The trial elements are used to support the selection of the appropriate device element with the size matching the anatomical needs of the patient, during the implantation of system elements. The instruments are required for the implantation or removal of the system elements, by temporary connection with the device during implantation or revision.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P09088001 | ACETABULAR RINGS |
| P09088002 | ACETABULAR MESHES |
| P09088003 | HIP PROSTHESES AUGMENTS |
| P09088004 | HIP PROSTHESES ADAPTERS (INCLUDING CONES AND SLEEVES) |
| P09088005 | HIP PROSTHESES CENTRALIZERS |
| P09088006 | FEMORAL INTRAMEDULLARY CAPS |
| P09088007 | HIP PROSTHESES FIXING SCREWS |
| P09088099 | HIP PROSTHESES - OTHER ACCESSORIES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | No. 5-903-200-2103 | NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC) | Expired |
Available In Countries
🇧🇬 Bulgaria
🇨🇿 Czechia
🇩🇪 Germany
🇬🇷 Greece
🇭🇷 Croatia
🇭🇺 Hungary
🇹🇷 Türkiye
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