FDA Registration
Active
🇰🇷 South Korea
T&L CO., LTD. ANSEONG FACTORY
Reg #: 3007417776
·
FEI: 3007417776
·
Expires 2026
Products
6
Proprietary Names
36
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- T&L CO., LTD. ANSEONG FACTORY
- Registration Number
- 3007417776
- FEI Number
- 3007417776
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 70-17, WONAM-RO, WONGOK-MYEON
- City
- ANSEONG-CITY Gyeonggi
- Country
- KR
Owner / Operator
- Firm Name
- T&L CO., LTD.
- Operator Number
- 9063857
- Address
- 27,Hyeongjero45Beon-gil,Namsa-myeon, Cheoin-gu-GU
- City
- Yongin-si
- State
- Gyeonggi
- Postal Code
- 17554
- Country
- KR
- Correspondent
- Hyun-Ju - Im
US Agent
- Business Name
- MEDIRECH GROUP LLC
- Contact Name
- Paul Lee
- Address
- Suite 8474, 2108 N St
- City
- Sacramento
- State
- CA
- ZIP
- 95816
- Country
- US
- [email protected]
- Phone
- 201 4634171
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2009-12-28 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2009-12-28 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2018-12-23 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2009-12-28 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2018-12-23 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2008-11-28 |
Proprietary Names
RenoCare Fiber Dressing
RenoCare Alginate Dressing
RenoPad Premium
RenoFoam SB
CovaWoundTM Foam Non-Adherent Foam Dressing with Adhesive Border
RenoPad
RenoFoam
Cura C
CovaWoundTM Foam Non-Adherent Foam Dressing
RenoFoam FA
RenoFoam A
Algipack
RenoFoam F
RenoFoam S
RenoSiGel
RenoSiGel S
RenoSil SUN
RenoSil
RenoSiGel N
Reno PJ
Burn Cool Sheet
Burn Cool Spray
RenoGel N
RenoGel H
RenoGel F
RenoLiquid
RenoFix MB Nonwoven Plaster
RenoCare Soft
RenoFix H
RenoCare B
RenoFix NH
RenoFix N Nonwoven Plaster
RenoCare Hydrocolloid Dressing
Suprasorb H
RenoFix U roll Plaster
RenoFix F
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device