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성공 프로젝트 사례 (Successful Project Cases)

바로 확인할 수 있는 결과

Conversation Between Colleagues
Informative Interview
Standing Meeting
Standing Meeting

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

 

IndiaSouth 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

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