FDA Registration
Active
🇹🇭 Thailand
Swicker Z100SORB with Radiopaque Ink Dots Non-Sterile, MP5207I-SY; MP5208I-SY; MP5209I-SY; MP5301I-SY; MP5302I-SY
Reg #: 3009470597
·
FEI: 3009470597
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FOAMTEC INTERNATIONAL CO., LTD.
- Registration Number
- 3009470597
- FEI Number
- 3009470597
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Export Proc. Zone 1, Laem Chabang Ind Es, 259/1 Moo 3, Toongsukla
- City
- A. Sriracha Chon Buri
- Country
- TH
Owner / Operator
- Firm Name
- Foamtec International Co., Ltd.
- Operator Number
- 10040498
- Address
- Export Proc. Zone 1, Laem Chabang Ind Es, 259/1 Moo 3, Toongsukla
- City
- A. Sriracha
- State
- Chon Buri
- Postal Code
- 20230
- Country
- TH
- Correspondent
- Thng Cheok Long
US Agent
- Business Name
- Foamtec International, LLC
- Contact Name
- Michael Strauss
- Address
- 720 Venture Dr
- City
- Waco
- State
- TX
- ZIP
- 76712
- Country
- US
- [email protected]
- Phone
- 254 7088137
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2022-05-09 |
Proprietary Names
Swicker Z100SORB with Radiopaque Ink Dots Non-Sterile, MP5207I-SY; MP5208I-SY; MP5209I-SY; MP5301I-SY; MP5302I-SY
Swicker Z100SORB with Radiopaque Ink Dots Non-Sterile, MP5202I-SY; MP5302I-SY; MP5402I-SY
Swicker Z100SORB with Radiopaque Ink Dots Non-Sterile, MP5304I-SY; MP5305I-SY; MP5306I-SY; MP5307I-SY; MP5308I-SY
Swicker Z100SORB with Radiopaque Ink Dots Non-Sterile, MP5406I-SY; MP5407I-SY; MP5408I-SY; MP5409I-SY
Swicker Z100SORB with Radiopaque Ink Dots Non-Sterile, MP5309I-SY; MP5401I-SY; MP5402I-SY; MP5404I-SY; MP5405I-SY
Swicker Digit Z100SORB with Radiopaque Ink Dots Non-Sterile, MP5500I-SY
Swicker Mitt Z100SORB with Radiopaque Ink Dots Non-Sterile, MP5501I-SY
Swicker Z100SORB with Radiopaque Ink Dots Non-Sterile, MP5201I-SY; MP5202I-SY; MP5204I-SY; MP5205I-SY; MP5206I-SY
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)