Company history
To obtain first-class medical device license (Soluzione Silicone Scar gel (Non-Sterile)
To obtain certificate of ISO 13485:2016 (DNV)
To obtain the membership certificate of Taiwan Cosmetics Industry Association.
ISO 13485:2016 First year regular audit completed
To obtain second-class medical device license (SavDerm Ag Aquafabric plus (Sterile)
Certificate of SNQ (NuROs Bone Graft Substitute)
To obtain a license for export-specific medical equipment (Oxy Anti-Bacterial Acne Patch)
ISO 13485:2016 Second year regular audit completed, 2016
To obtain first-class medical device license (SavDerm Aqua Plus dressing(Sterile)
Certificate of SNQ (NuROs Bone Graft Substitute)
To obtain first-class medical device license (SavDerm Hydrocolloids Dressing(Sterile)
To obtain GMP certificate (items: Silicone scar management product,Occlusive wound/burn dressing, Nonresorbable gauze/sponge for external use, Hydrophilic wound dressing, Liquid bandage, Bone grafting material, Resorbable calcium salt bone void filler device, Cement dispenser, Medical adhesive tape and adhesive bandage
To obtain first-class medical device license (SavDerm Medical Mask(Non-Sterile)
ISO 13485:2016 First year regular audit completed
Certificate of SNQ:NuROs Bone Graft Substitute
To obtain certificate : ISO 13485, 2016(BSI)
ISO 13485:2016 First year regular audit completed
To obtain first-class medical device license (Mentholatum Acnes Dressing(Sterile)
To obtain a license for export-specific medical equipment (Mentholatum Spot Dressing)
To obtain a license for export-specific medical equipment (Men's Spot Dressing)
To obtain second-class medical device license (NexFill NEO Composite Dental Plaster(Sterile)
To obtain first-class medical device license (SavDerm Porous PU Foam Dressing(Sterile)
Certificate of SNQ (NuROs Bone Graft Substitute)
To obtain second-class medical device license (Mentholatum Acnes Acne Patch)
To obtain second-class medical device license (Mentholatum Clear Patch)
To obtain second-class medical device license (VitOs Injectable Bone Graft substitute (Sterile)
To obtain FDA 510(k) (K140913) (NuROs Bone Graft Substitute)
Certificate of SNQ, Symbol of national Quality (NuROs Bone Graft Substitute)
To obtain first-class medical device licens (SavDerm Beige Scar Gel)
To obtain a license for export-specific medical equipment: Acnes Medicated Anti-bacteria Spot Dressing, Mentholatum Acnes Anti-Bacterial Acne Patch,Mentholatum Acnes Acne Patch, Acnes Medicated Anti-bacteria Spot Dressing
To obtain second-class medical device license (Antiseptic Hydrocolloids Dressing).
Awarded Symbol of National Quality Bronze in the Medical Equipment Section, Medical Appliance Category (NuROs Bone Graft Substitute)
Participated in the R.O.C Fine Product Evaluation and was approved by the evaluation committee, including to SavDerm Antiseptic Hydrocolloids Thin Dressing,SavDerm Antiseptic Wound Dressing,SavDerm Wound Closure Strip Kit,Kilmicron General Purpose Disinfectants.
To obtain special material paid points of National Health Insurance of Antiseptic Hydrocolloids Thin Dressing、Aquafabric dressing
Listing a series of wound dressing in FDA
To obtain certificate of CE Marking (Wound dressing (non-sterile)
To obtain first-class medical device license (General Purpose Disinfectants).
To obtain first-class medical device license (Aquafabric dressing).
To obtain certificate of CE Marking (Wound dressing (non-sterile)
To obtain special material paid points of National Health Insurance of Bone Graft Substitute、Hydrogel
To obtain Third-class medical device license (Dental Bone Graft)
To obtain second-class medical device license ( Antiseptic Hydrocolloids Thin Dressing and Antiseptic Acne Dressing).
To obtain first-class medical device license (Medical Adhesive Strips).
To obtain second-class medical device license (Bone Graft Substitute).
To obtain first-class medical device license ( Hydrogel).
To obtain first-class medical device license ( Liquid Bandage).
To obtain second-class medical device license (Antiseptic Wound Dressing).
To obtain first-class medical device license (Silicone Scar gel).
To obtain certificate of CE Marking (Sterile Wound Dressing (IIa), Sterile Injectable Bone Graft Substitute (IIb) )
To obtain first-class medical device license (Alginate dressing).
To obtain first-class medical device license (Kinesiology Tape).
To obtain first-class medical device license (Alginate dressing).
To obtain certificate of ISO 13485:2003 (add new items).
To obtain GMP license: new items (hydrophilic wound dressing).
To obtain special material paid points of National Health Insurance of biocellulose film.
To obtain certificate of membership of Taiwan Medical and Biotech Industry Association.
To obtain second-class medical device license (injectable bone graft substitute).
To obtain special material paid points of National Health Insurance of hydrocolloid thin dressing.
To obtain first-class medical device license (hydrocolloid thin dressing, acne dressing, hydrophilic wound dressing).
Completed the ISO13485 third year of regular checks.
To obtain first-class medical device license (umbilical truss).
To obtain special material paid points of National Health Insurance of self-adhesive foam dressing.
To obtain first-class medical device license (self-adhesive foam dressing).
To obtain second-class medical device license (biocellulose film).
Obtained the payment points for special materials of national health insurance for foam dressings (5x5, 10x20, 20x20cm).
To obtain first-class medical device license (Silicone Scar-care Dressing (Beige)).
To obtain first-class medical device license (Silicone Scar-care Dressing (Beige)).
To obtain first-class medical device license (Foam Island Wound Dressing).
To obtain GMP license: wound dressing, biocellulose film, silicone care dressing.
To obtain certificate of ISO 13485:2003.
To obtain first-class medical device license (silicone care dressing, foam island wound dressing, wound dressing, foam dressing).
Completed the ISO13485 first year of regular checks.
Proposed GMP factory inspection applications (New Items).
Biomedical Business Unit of Far Eastern group reorganized to be Oriental Resources Development Limited.
To obtainTaiwan ministry of Health approval number (wound dressing).
To obtain ISO 13485:2003 certificate (No.3971-2007-AQ-NOR).
To obtain first-class medical device license (dressings for wound exudate, sterile dressing).
To obtain medical device good manufacturing practice(GMP);certificate in Chinese and English.
To obtain drug manufacturer license.
To apply changes for factory registration (added medical device industry).
Biomedical plant in Hukou completed acceptance of the construction.
Machine acceptance of wound dressing.
Far Eastern Textile Ltd. added business items in medical device manufacturing, wholesale and retail.
Biomedical plant in Hukou started-up.
Biomedical Business Unit formally established.
To obtain patents in Taiwan, mainland China (wound dressing).
To obtain approval of Biomedical plant-construction permit.
Biomedical dressing project got approved.
Established Preparatory Office in New Products Commercialized Department of Far Eastern Textile Ltd. and began to develop medical device business and recruit for staff.