Eu Mdr
Eu Md Class 3
On The Market
๐ฎ๐น Italy
RegenOss Ortho
Devices (same UDI-DI)
7
Certificates
1
Countries
6
Notified Bodies
1
Basic Information
- Primary DI
- 18054188160529
- Basic UDI-DI Code
- 805418816RegenOssKS
- Reference
- 1600815
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Fin-ceramica faenza spa
Additional Description
RegenOss is an implantable, resorbable, non-active medical device that acts as a bone substitute. It consists of type I collagen (equine origin) and hydroxyapatite enriched with magnesium ions
CND Nomenclature Codes
| Code | Description |
|---|---|
| P900402 | RESORBABLE FILLING AND RECONSTRUCTION DEVICES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDR Technical Documentation | CVD 0005-23 | ISTITUTO SUPERIORE DI SANITA' |
Available In Countries
๐ง๐ช Belgium
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ช๐ธ Spain
๐ฎ๐น Italy
๐ต๐น Portugal
Related Devices
The Basic UDI-DI associated with this device has 7 devices in total. Below are some other devices sharing the same Basic UDI-DI.
RegenOss Spine
Device
EU MDR
·
Eu Md Class 3
·Fin-ceramica faenza spa·On the market·4 countries
RegenOss Spine
Device
EU MDR
·
Eu Md Class 3
·Fin-ceramica faenza spa·On the market·4 countries
RegenOss Ortho
Device
EU MDR
·
Eu Md Class 3
·Fin-ceramica faenza spa·On the market·4 countries
RegenOss Ortho
Device
EU MDR
·
Eu Md Class 3
·Fin-ceramica faenza spa·On the market·4 countries
RegenOss Ortho
Device
EU MDR
·
Eu Md Class 3
·Fin-ceramica faenza spa·On the market·4 countries
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