성공 프로젝트 사례 (Successful Project Cases)
바로 확인할 수 있는 결과
CE Medical device
(MDD/ MDR)
Class I
1. Spine fixation chair
2. Specimen collector
3. Dental accessories
Class IIa
1. Orthodontic Ceramic Bracket
2. Orthodontic Bracket & Wire
3. PACS (Picture Archiving and Communication System)
4. AI base X ray image Bone Age Assessment system
5. AI base Computer-Aided Processing Software
6. Drug Infusion Monitor
7. Micro needle
8. Hair implant needle
9. Infusion needle
10. Sterile Platelet-Rich Plasma Blood Separation Kit
11. Dental hand piece
12. Ultrasonic irrigation
13. Primary Crown
14. Dental brush
Class IIb
1. Dental GBR system
2. Facial silicone implant
3. Drug Infusion Monitor
4. Dental Abutment & Fixture
5. Ceramic Abutment
6. Focused Ultrasound Stimulator Use System
7. Picosecond Nd:YAG Laser
8. Radiological computer-assisted diagnostic software
Class III
1. PDO suture with Needle
2. Hemostatic peel away introducer system for vascular access
CE In vitro diagnostic
(IVD/ IVDR)
Others
1. Staining reagent for cell and tissue pathology tests
2. Influenza Rapid kit
3. Malaria Rapid kit
4. Dengue NS1 Rapid kit
5. Rota/Adeno Rapid kit
6. Cardiac diagnosis kit
7. Troponin I diagnosis kit and etc
Class List B
1. PSA test
Self-test
1. Pregnancy test kit
US FDA
(510K)
510K
1. Spine cage
2. Intraoral camera
3. DNA analyzer
4. Spinal system
5. Dressing, Wound, Drug
6. Dental handpiece and accessories
7. Ear, Nose, And Throat Synthetic Polymer Material
MFDS
(Ministry of Food and
Drug Safety)
Class 1
1. Wound dressing
2. Specimen collector
3. Nucleic acid extractor
4. Vaginal endoscope
5. Endoscopic clip
6. Clinical Chemistry Analyzer
7. IVD analyzer for self-test
Class 2
1. Urine chemistry test kit
2. Pregnancy test kit
3. CRP test kit and etc
Class 3
1. COVID-19 Detection Kit
2. COVID 19 Ag Home Test
3. Dental implant
4. Lumbar Expandable Cage System
Class 4
1. Hemostatic peel away introducer system for vascular access
2. Polydioxanone suture with needle
3. Cardiovascular stent
Global registration
NMPA (China)
1. Facial silicone implant
2. Cardiac diagnosis kit
3. Troponin I diagnosis kit
4. PSA test
5. PDO suture with Needle
TFDA (Taipei)
1. PDO suture with Needle
ANVISA (Brazil)
1. Urine chemistry test kit
2. Pregnancy test kit
3. IVD analyzer for self-test
India, South East Asia, Arabic countries, African countries and South America countries
1. Cardiac diagnosis kit
2. Troponin I diagnosis kit
3. PSA test
4. Urine chemistry test kit
5. Pregnancy test kit
6. CRP test kit and etc
Quality management
ISO13485
10 Companies
KGMP
7 Companies