Eu Mdd
Eu Md Class 2a
On The Market
🇩🇪 Germany
Trial and Instrument accessories for Biotech Pectus Bar Correct System
Devices (same UDI-DI)
1
Certificates
1
Countries
3
Notified Bodies
1
Basic Information
- Primary DI
- D-4049852PE2DNU8
- Basic UDI-DI Code
- B-4049852PE2DNU8
- Reference
- 4049852PE2DN
- 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 Pectus Bar Correct System”. 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 |
|---|---|
| P099003 | ORTHOPAEDIC PROSTHESES FIXING ELEMENTS - NOT OTHERWISE CLASSIFIED |
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
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).
Coiled Tubing
Device
EU MDD
·
Eu Md Class 2a
·Liebel-Flarsheim Company, LLC ·On the market·2 countries
Sterivap HP
Device
EU MDD
·
Eu Md Class 2a
·BMT Medical Technology s.r.o.·On the market·9 countries
Sterivap
Device
EU MDD
·
Eu Md Class 2a
·BMT Medical Technology s.r.o.·On the market·9 countries
Selectomat SL
Device
EU MDD
·
Eu Md Class 2a
·BMT Medical Technology s.r.o.·On the market·2 countries
Sterivap SL
Device
EU MDD
·
Eu Md Class 2a
·BMT Medical Technology s.r.o.·On the market·7 countries
Unisteri HP
Device
EU MDD
·
Eu Md Class 2a
·BMT Medical Technology s.r.o.·On the market·8 countries