 |  |
| Certifications | Date | Organization | Marking |
|---|---|---|---|
| Directive 93-42-ECC (CD certification) |
2008.03.24 | TUV Rheinland |  |
| ISO 9001-2000 | 2008.03.24 | TUV Rheinland | |
| ISO 13485-2003 | 2008.03.24 | TUV Rheinland | |
| 기업부설연구소 (Company Research Institute) |
2009.09.14 | 한국산업기술진흥협회 (Koita) |
 |
| 벤처기업(Venture Company) | 2008.06.18 | 기술보증기금(Kibo) |  |
| 의료기기 품질관리기준 적합인정 (KGMP) |
2008.11.05 | 산업기술 시험원(KTL) |  |
| 신기술인증 (New Technology Certification) |
2005.10.03 | 지식경제부 기술표준원(Korean Agency for Technology and Standards) |
 |
| 제조업허가(Korean medical device manufacturer) |
2002.07.12 | 식품의약품안전청(KFDA) |  |
| FDA registration | 2008.08.28 | 식품의약품안전청(KFDA) | Registration Number : 3007120332 Owner Operator Number : 10026862 |
| FDA 510K | 2009.02.10 | 미식품의약품안전청(FDA) |  |
| PAL GMP (P5-1) | 2008.03.17 | SGS 인증원 | PAL GMP |
| UL(P5-1) | 2008.01 | UL Korea |  |
| MHLW registration | 2009.03.13 | TUV Rheinland | |
| CMDCAS | 2009.10.30 | TUV Rheinland |  |
| INNO-BIZ | 2010.03.04 | 중소기업청 |  |
