 |  |
| Certifications | Date | Organization | Marking |
|---|---|---|---|
| Directive 93-42-ECC (CD certification) |
24-Mar-08 | TUV Rheinland |  |
ISO 9001-2000 |
24-Mar-08 | TUV Rheinland | |
ISO 13485-2003 |
24-Mar-08 | TUV Rheinland | |
| Company Research Institute |
14-Sep-09 | Korea Industrial Technology Association |
 |
| Venture Company | 18-Jun-08 | Korea Technology Finance Corperation |
 |
| Korea Good Manufacturing Practice(KGMP) |
5-Nov-08 | Korea Testing Laboratory |  |
| New Technology Certification | 3-Oct-05 | Korean Agency for Technology and Standards |
 |
| Korean medical device manufacturer |
12-Jul-02 | Korea Food and Drug Administration |  |
| FDA registration | 28-Aug-08 | Korea Food and Drug Administration | Registration Number : 3007120332 Owner Operator Number : 10026862 |
| FDA 510K | 10-Feb-09 | Food and Drug Administration |  |
| PAL GMP (P5-1) | 17-Aug-08 | SGS | PAL GMP |
| UL(P5-1) | an-08 | UL Korea |  |
| MHLW registration | 13-Mar-09 | TUV Rheinland | |
| CMDCAS | 30-Oct-09 | TUV Rheinland | |
| INNO-BIZ | 4-Mar-10 | SMBA |  |
