| Product (group) |
CE Class. Product |
MDR CAN |
510K or Other |
EN ISO 9001:2000 |
EN ISO 13485:2003 |
| Wound treatment products |
| Non-wovens/ gauzes |
IIa |
|
|
|
x |
| Wound dressings for severe and chronic wounds |
IIb |
|
|
|
|
| Hemostats |
III |
|
|
x |
x |
| Medical devices with animal tissue derived components |
III |
|
|
|
|
| Dental products |
| Dental implants and accessories |
IIa & IIb |
|
|
x |
x |
| Tooth whitener |
IIa |
|
|
|
|
| Surgical products and accessories |
| Cardiac surgery devices |
III |
|
510K |
x |
x |
| Blood circulation system custom packs |
IIa |
|
|
x |
|
| HA-Coated Implants |
III |
|
|
x |
x |
| Surgical Mesh |
IIb |
|
|
|
|
| Contraceptives |
| Intra uterine devices |
III |
III |
|
x |
x |
| Contraceptive products |
IIb |
|
|
x |
x |
| Preventive / Treatment supporting products |
| Anti-decubitus mattresses and cushions |
I |
|
|
x |
x |
| Foreign Submissions |
Product Submissions have been achieved in:
Bosnia, Brasil, Canada, Croatia, Czech Republic, Egypt, Estonia / Latavia
/ Lithuania, Hongary, Indonesia, Philippines, Poland, Russia, Serbia, Singapore,
Slovakia, Slovenia, Taiwan, Ukraine, US |
| Quality Management Systems |
| Design and development of (micromechanical) medical devices |
|
|
|
|
x |
