FDA Registration
Active
🇰🇷 South Korea
DASOL INTERNATIONAL LTD.
Reg #: 3007050292
·
FEI: 3007050292
·
Expires 2026
Products
10
Proprietary Names
48
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- DASOL INTERNATIONAL LTD.
- Registration Number
- 3007050292
- FEI Number
- 3007050292
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- #606 KoFoMo TechnoCenter 341, Gongdan 1-daero (Jeongwang-dong)
- City
- Siheung-Si Gyeonggi
- Country
- KR
Owner / Operator
- Firm Name
- Dasol International Ltd.
- Operator Number
- 10025904
- Address
- #615 KoFoMo TechnoCenter 341, Gongdan 1-daero (Jeongwang-dong)
- City
- Siheung-Si
- State
- Gyeonggi
- Postal Code
- 429-450
- Country
- KR
US Agent
- Business Name
- Piscium International, Inc
- Contact Name
- John Choi
- Address
- 1324 Azalea Dr
- City
- North Brunswick
- State
- NJ
- ZIP
- 08902
- Country
- US
- [email protected]
- Phone
- 215 7791283
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Microscope, Surgical | EPT | Class 1 | General, Plastic Surgery | No | 2008-05-20 |
| Drape, Microscope, Ophthalmic | HMW | Class 2 | General, Plastic Surgery | No | 2021-08-11 |
| Dress, Surgical | FYE | Class 1 | General, Plastic Surgery | No | 2017-09-27 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2015-02-09 |
| Curtain, Protective, Radiographic | IWQ | Class 1 | Radiology | No | 2017-09-27 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-05-25 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2008-05-20 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2008-11-04 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2020-05-25 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-09-27 |
Proprietary Names
DASOL
DASOL Ophthalmic Drape
PE Gown: RA3031
PE Gown (Non-Sterile)
DSA302 PE Gown w/cuff sterilized
PE Gown (Sterile)
Sani-Needle
C-Arm Drape: DSC200
Head Cover: DSH100, DSH100A
Respir~e Mask
Sani-Sleeve
Sani-Sleeve w/Inner Ring (DS6S16IR)
Povidone-Iodine Swabsticks
Alcohol Swabsticks
Alcohol Prep Pads
DASOL Isolation Gown
DASOL COVERALL Protective Clothing
Knee Arthroscopy Pack I
Knee Pack VII
C-Section Pack
Universal Pack
General Spine Pack, PELD Spine Pack
Bilateral Limb Pack
Shoulder Arthroscopy Pack I, BC Shoulder Arthroscopy Pack I
TUR Pack
Pediatric Laparotomy Pack
Craniotomy Pack
Rectal & Colon Pack I
Hip Pack
LAVH Pack
Hand Pack I
Breast Pack I, Breast Pack
Femoral Angiography Pack
Thyroid Pack
Laparotomy Pack
Laparoccopy Pack II, Laparoccopy Pack
Ultra-Sleeve
DASOL CSR Wrap WR99
DASOL CSR Wrap WR33
DASOL CSR Wrap WR88
DASOL CSR Wrap WR100
DASOL CSR Wrap WR34
DASOL CSR Wrap WR120
DASOL CSR Wrap WR110
DASOL CSR Wrap WR160
DASOL CSR Wrap WR66
DASOL CSR Wrap WR77
DASOL CSR Wrap WR55
Establishment Types
Manufacture Medical Device
Sterilize Medical Device for Another Party (Contract Sterilizer)