Eu Mdd
Eu Md Class 3
On The Market
🇩🇪 Germany
Biotech Modular Shoulder System (BMS)
Devices (same UDI-DI)
1
Certificates
2
Countries
3
Notified Bodies
2
Basic Information
- Primary DI
- D-4049852SH1ECV6
- Basic UDI-DI Code
- B-4049852SH1ECV6
- Reference
- 4049852SH1EC
- Device Types
-
Single use Sterile Sterilization
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Biotech GmbH
Additional Description
Biotech Modular Shoulder System (BMS) is a non-active surgical implant system for a joint replacement (shoulder prosthesis -components of a complete joint implantable prosthesis - excluding ancillary components - that are similar in function to a natural shoulder joint). It is a modular device, with a cemented or cementless design with device-specific accessories. Its a long-term, implantable device in class III. The device elements are made of metal (CoCr alloy, titanium alloy, stainless steel) and plastic (UHMWPE) raw materials.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P09010301 | METAL BACK AND METAGLENE GLENOID BASEPLATES [correction as of 2025-01-01] |
| P09010302 | ANATOMICAL SHOULDER PROSTHESIS INSERTS |
| P09010303 | GLENOSPHERES |
| P09010304 | MONOBLOCK GLENOIDS |
| P09010399 | GLENOID COMPONENTS - OTHER |
| P090104010101 | EPIPHYSARY HUMERAL COMPONENTS FOR ANATOMICAL PROSTHESES - HUMERAL HEADS |
| P090104010102 | EPIPHYSARY HUMERAL COMPONENTS FOR RESURFACING ANATOMICAL PROSTHESES |
| P090104010201 | EPIPHYSARY HUMERAL COMPONENTS FOR REVERSE PROSTHESES - INSERTS |
| P090104010202 | EPIPHYSARY HUMERAL COMPONENTS FOR REVERSE PROSTHESES - HUMERAL CUPS |
| P0901040199 | EPIPHYSARY HUMERAL COMPONENTS - OTHER |
| P0901040201 | SHOULDER PROSTHESES NON MODULAR STEMS |
| P0901040202 | SHOULDER PROSTHESES MODULAR STEMS |
| P090104020301 | MONOBLOCK DIAPHYSARY HUMERAL COMPONENTS FOR ANATOMICAL PROSTHESIS (STEM + HEAD) |
| P090104020302 | MONOBLOCK DIAPHYSARY HUMERAL COMPONENTS FOR REVERSE PROSTHESIS (STEM + CUP) |
| P0901040204 | SHOULDER PROSTHESES REVISION STEMS |
| P0901040205 | SHOULDER PROSTHESES LARGE RESECTIONS STEMS |
| P0901040299 | DIAPHYSARY HUMERAL COMPONENTS - OTHER |
| P09010403 | SHOULDER PROSTHESES SPACERS |
| P09010499 | HUMERAL COMPONENTS FOR SHOULDER PROSTHESES - OTHER |
| P090199 | SHOULDER PROSTHESES - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | No. 5-903-200-2123 | NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC) | Expired |
| MDD Annex II Section 4 | No. 5-927-204-2105 | NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC) | Expired |
Available In Countries
🇩🇪 Germany
🇭🇷 Croatia
🇭🇺 Hungary
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