| Category |
Certificate No. |
Certifying Authority |
| Establishment |
Factory Registration No. 90-K00914, 90-K00990 |
Export Processing Zone
Administration, Ministry
of Economic Affairs, Taiwan, R.O.C.
|
| Pharmaceutical Manufacturer License No. MD6107000642 |
Department of Health, Kaohsiung City Government, Taiwan, R.O.C. |
| Pharmaceutical Dealer License No. 6202095669 |
Department of Health, Kaohsiung City Government, Taiwan, R.O.C. |
Quality
Management Sysytem |
GMP registration No. GMP 0291, QMS 1607 |
Ministry of Health and Welfare, Taiwan, R.O.C. |
| ISO 13485 Certificate No. MD 621215 |
BSI |
HALAL |
HALAL Decree for Medical Device, No. 00170110741120 |
LPPOM MUI |
Medical
Device |
CFS for Sodium Hyaluronate Facial Dermal Implant, DOH-MD-No. 003035 (example as HYADERMIS) |
Ministry of Health and Welfare, Taiwan, R.O.C. |
| CFS for Sodium Hyaluronate Facial Dermal Implant with Lidocaine, MOHW-MD-No. 004234 (example as HYADERMIS LA) |
Ministry of Health and Welfare, Taiwan, R.O.C. |
| CFS for Triple-Injection Sodium Hyaluronate Synovial Fluid Supplement, DOH-MD-No. 002490 (example as HYAJOINT) |
Ministry of Health and Welfare, Taiwan, R.O.C. |
| CFS for Single-Injection Sodium Hyaluronate Synovial Fluid Supplement, MOHW-MD-No. 004511 (example as HYAJOINT Plus) |
Ministry of Health and Welfare, Taiwan, R.O.C. |
| CFS for Stabilized Sodium Hyaluronate Synovial Fluid Supplement, MOHW-MD-No. 006904 (example as JETKNEE) |
Ministry of Health and Welfare, Taiwan, R.O.C. |
| CFS for Sodium Hyaluronate Intravesical Instillation, MOHW-MD-No. 005696 (example as HYAURO) |
Ministry of Health and Welfare, Taiwan, R.O.C. |
| CFS for Sodium Hyaluronate Absorbable Adhesion Barrier, MOHW-MD-No. 005697 (example as PROTAHERE) |
Ministry of Health and Welfare, Taiwan, R.O.C. |
| CFS for Sodium Hyaluronate Hydrogel Wound Dressing, DOH-MD-(I)-No. 003488 (example as DERMACOAT) |
Ministry of Health and Welfare, Taiwan, R.O.C. |
| CFS for Sodium Hyaluronate Wound Repair Hydrogel, MOHW-MD-(I)-No. 006170 (example as FACILLE Spring) |
Ministry of Health and Welfare, Taiwan, R.O.C. |
| CFS for Sodium Hyaluronate Intranasal Splint, MOHW-MD-(I)-No. 005895 (example as HYACOVER) |
Ministry of Health and Welfare, Taiwan, R.O.C. |
| Sodium Hyaluronate Tissue Augmentation Device EC Design-Examination Certificate No. CE 621433 |
BSI |
| Sodium Hyaluronate Tissue Augmentation Device with Lidocaine EC Design-Examination Certificate No. CE 621434 |
BSI |
| Sodium Hyaluronate Synovial Fluid Supplement EC Design-Examination Certificate No. CE 621435 |
BSI |
