Eu Mdd
Eu Md Class 2b
On The Market
🇩🇪 Germany
Biotech Pectus Bar Correct System
Devices (same UDI-DI)
1
Certificates
1
Countries
3
Notified Bodies
1
Basic Information
- Primary DI
- D-4049852PE1DLTX
- Basic UDI-DI Code
- B-4049852PE1DLTX
- Reference
- 4049852PE1DL
- Device Types
-
Single use Sterile Sterilization
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Biotech GmbH
Additional Description
Biotech Pectus Bar Correct System is a non-active surgical implant system using for Pectus Excavatum deformity treatment. Its a long-term, implantable device in class II b. The product is a so-called osteosynthesis implant and within it a device for the treatment of pectus excavatum. The device elements are made of metal (titanium alloy, stainless steel) raw materials.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P9099 | IMPLANTABLE PROSTHETIC DEVICES - OTHER |
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
🇦🇹 Austria
🇭🇺 Hungary
🇬🇧 United Kingdom
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