FDA Registration
Active
🇰🇷 South Korea
i-Thread
Reg #: 3015812758
·
FEI: 3015812758
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HYUNDAE MEDITECH CO., LTD.
- Registration Number
- 3015812758
- FEI Number
- 3015812758
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 80, Cheongjeong-ro, Jijeong-myeon
- City
- Wonju Gangwon
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K242571
Owner / Operator
- Firm Name
- Hyundae Meditech Co., Ltd.
- Operator Number
- 10080349
- Address
- 80, Cheongjeong-ro, Jijeong-myeon
- City
- Wonju
- State
- Gangwon
- Postal Code
- 26347
- Country
- KR
- Correspondent
- Young Ho Song
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2025-06-16 |
Proprietary Names
i-Thread
Establishment Types
Manufacture Medical Device