FDA Registration
Active
🇻🇳 Vietnam
CPT SUTURES CO., LTD.
Reg #: 3018064853
·
FEI: 3018064853
·
Expires 2026
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CPT SUTURES CO., LTD.
- Registration Number
- 3018064853
- FEI Number
- 3018064853
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8 Dao Tri Street, Phu Thuan Ward
- City
- Ho Chi Minh City
- Country
- VN
Regulatory Submissions
- 510(k) Number
- K170166
Owner / Operator
- Firm Name
- CPT SUTURES CO., LTD.
- Operator Number
- 10080643
- Address
- 8 Dao Tri Street, Phu Thuan Ward
- City
- Ho Chi Minh
- State
- VN-SG
- Postal Code
- 700000
- Country
- VN
- Correspondent
- Khoa Do
US Agent
- Business Name
- RAF SOLUTIONS INC
- Contact Name
- Edwin Lindsay
- Address
- 10124 Nw 53rd St
- City
- Sunrise
- State
- FL
- ZIP
- 33351
- Country
- US
- [email protected]
- Phone
- 305 9607262
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2021-02-17 |
Proprietary Names
CARESORB® - Polyglactin 910; CARESORB® RAPID (fast absorbing)
TEKSYN® PGA - Polyglycolic Acid (PGA); Rapid, Synthetic Absorbable Suture
TEKSYN® 910 - Polyglactin 910 (PGLA); Rapid (fast absorbing)
CARESYN® - Polyglycolic Acid; CARESYN® RAPID, Synthetic Absorbable Suture
Establishment Types
Manufacture Medical Device