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Certificate of Registration  
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Quality and Compliance
SciVision’s Quality Policy: Quality Priority and Customer Satisfaction Focus  
Glossary

Certificate No.

Certifying Authority
Establishment Factory Registration No. 90-K00914 Export Processing Zone
Administration, Ministry
of Economic Affairs, Taiwan, R.O.C.
Pharmaceutical Manufacturer License No. 6102091061 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 Ministry of Health and Welfare, Taiwan, R.O.C.
ISO 13485 Certificate of Registration No. MD 621215 BSI
ISO 13485 Certificate of Registration No. CERT-0099655 SAI Global
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 Lidocane, 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. 002490 (example as HYAJOINT Plus) Ministry of Health and Welfare, Taiwan, R.O.C.
CFS for Hydroxylapatite Tissue Filler, DOH-MD-(E)-No.000383 (example as PerleDermis) 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 Patient Lubricant, DOH-MD-(I)-No. 003556 (example as INDOLLE) Ministry of Health and Welfare, Taiwan, R.O.C.
CFS for Sodium Hyaluronate Wound Repair Hydrogel, MOHW-MD-(I)-No. 006352 (example as HYADERMIS 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 Synovial Fluid Supplement EC Design-Examination Certificate No. CE 621435 BSI
Hydroxylapatite Tissue Augmentation Device EC Design-Examination Certificate No. CE 633899 BSI
Sodium Hyaluronate Hydrogel Wound Dressing Certificate of CE Notification No. IO 3526-2014 Obelis S.A.