FDA Registration
Active
🇰🇷 South Korea
SEWOON MEDICAL CO., LTD.
Reg #: 3000247987
·
FEI: 3000247987
·
Expires 2026
Products
10
Proprietary Names
3
Establishment Types
5
Classifications
10
Registration Details
- Registration Name
- SEWOON MEDICAL CO., LTD.
- Registration Number
- 3000247987
- FEI Number
- 3000247987
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 60, Dorim-gil, Ipjang-myeon, Seobuk-gu,
- City
- Cheonan-si Chungnam
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K092144
Owner / Operator
- Firm Name
- SEWOON Medical Co., Ltd.
- Operator Number
- 9036109
- Address
- 60 Dorim-gil, Ipjang-myeon, Seobuk-gu
- City
- Cheonan-si
- State
- Chungnam
- Postal Code
- 31061
- Country
- KR
- Correspondent
- Jaehee Lee
US Agent
- Business Name
- Allura Medical Solution Inc.
- Contact Name
- SOOJUNG MOON
- Address
- 5485 Rathdrum Way
- City
- Antioch
- State
- CA
- ZIP
- 94531
- Country
- US
- [email protected]
- Phone
- 407 2429796
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 1999-01-08 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2021-09-23 |
| Prosthesis, Esophageal | ESW | Class 2 | General, Plastic Surgery | No | 2012-05-10 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2012-05-10 |
| Support, Breathing Tube | JAY | Class 1 | Anesthesiology | No | 2008-12-04 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 1999-01-08 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2008-01-16 |
| Bag, Drainage, With Adhesive, Ostomy | FON | Class 1 | Gastroenterology, Urology | No | 1999-01-08 |
| Prosthesis, Tracheal, Expandable | JCT | Class 2 | General, Plastic Surgery | No | 2016-07-25 |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | Class 2 | Gastroenterology, Urology | No | 1999-01-08 |
Proprietary Names
Barovac
Bonastent
Temp Foley
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device