Eu Mdd Eu Md Class 3 On The Market 🇰🇷 South Korea

GOURI

DEXLEVO INC. · 🇰🇷 South Korea
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1

Basic Information

Primary DI
08800077300001
Basic UDI-DI Code
B-08800077300001
Reference
DLMR
Device Types
Single use Sterile
Regulation
Eu Mdd
Classification
Eu Md Class 3
Status
On The Market
Manufacturer
DEXLEVO INC.

Additional Description

GOURI is a premium collagen simulator, a fully solubilized liquid form of Polycaprolactone (PCL). PCL is degraded by hydrolysis of its ester linkages in physiological conditions (such as in the human body) and has therefore received a great deal of attention for use as an implantable biomaterial. In particular, it is especially interesting for the preparation of long-term implantable devices, owing to its degradation which is even slower than that of polylactide. Polycaprolactone (PCL) has been widely used in long term implants and controlled drug release applications.

CND Nomenclature Codes

Code Description
P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES

Certificates

Type Number
MDD Annex II (excluding section 4) CE-MDD-0115/03/2021/01

Available In Countries

🇪🇸 Spain

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