FDA Registration
Active
🇹🇭 Thailand
FOAMTEC INTERNATIONAL CO., LTD.
Reg #: 3009470597
·
FEI: 3009470597
·
Expires 2026
Products
11
Proprietary Names
40
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- FOAMTEC INTERNATIONAL CO., LTD.
- Registration Number
- 3009470597
- FEI Number
- 3009470597
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Laemchabang Industrial Estate, Export Processing, 259/1 Moo 3, Toongsukhla
- City
- Sriracha Chon Buri
- Country
- TH
Owner / Operator
- Firm Name
- Foamtec International Co., Ltd.
- Operator Number
- 10040498
- Address
- Laemchabang Industrial Estate, Export Processing, 259/1 Moo 3, Toongsukhla
- City
- 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 |
|---|---|---|---|---|---|
| Tampon, Menstrual, Unscented | HEB | Class 2 | Obstetrics/Gynecology | No | 2026-04-23 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2018-12-12 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2022-05-09 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2012-11-14 |
| Unit, Cryosurgical, Accessories | GEH | Class 2 | General, Plastic Surgery | No | 2018-12-12 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2015-07-09 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2020-05-18 |
| System, X-Ray, Mammographic | IZH | Class 2 | Radiology | No | 2017-03-27 |
| Camera, Scintillation (Gamma) | IYX | Class 1 | Radiology | No | 2017-03-27 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2012-04-19 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2022-05-09 |
Proprietary Names
Tampon, Menstrual, Unscented - Livi Device, MP501-LIV
Endoscope Cleaners
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 Mitt Z100SORB with Radiopaque Ink Dots Non-Sterile, MP5501I-SY
Swicker Digit Z100SORB with Radiopaque Ink Dots Non-Sterile, MP5500I-SY
Swicker Z100SORB with Radiopaque Ink Dots Non-Sterile, MP5309I-SY; MP5401I-SY; MP5402I-SY; MP5404I-SY; MP5405I-SY
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, MP5201I-SY; MP5202I-SY; MP5204I-SY; MP5205I-SY; MP5206I-SY
NON081144NC, Adult Head Positioner; NON081147, Comfort Touch Head Positioner
HT4029-MD, Head Positioner, Ring7"; HT4032-MD, Slotted Foam Head Positioner
NON081340, Ulnar Nerve Cushion; NON081343, Foam Arm Board Pads; NON081344NC, Arm Cradle
NON081440, Heel Protector; NON081448, Abduction Pillow, Small
NON081449, Abduction Pillow, Medium; NON081450, Abduction Pillow, Large
HT4034-MD, Multi Ring Head Positioner; HT4035-MD, Foam Arm Board Pads; HT4036-MD, Arm Cradle
NON081244, Foam Positioning Wedge; NON081245, Disposable Foam Wedge
NON081141, Head Positioner, Ring 9"; NON081142, Head Positioner, Ring 7", NON081143, Slotted Foam Head Positioner
HT4055-MD, OR Eggcrate Pad; HT4066-MD, Abduction Pillow, Small; HT4067-MD, Abduction Pillow, Medium
HT4037-MD, Adult Head Positioner; HT4042-MD, Disposable Foam Wedge; HT4051-MD, Foam Positioning Wedge
HT4052-MD, Medicine Cup Holder; HT4054-MD, Head Positioner
103049, OR Eggcrate Pad; 103115, Head Positioner; 103496, Medicine Cup Holder; HT4028-MD, Comfort Touch Head Positioner
HT4068-MD, Abduction Pillow, Large; NON081140, Multi Ring Head Positioner
Swab Applicator, Arrow Tip Swab, HT1321; Swab Applicator, Arrow Tip Swab, HT1320
Swab Applicator, Round Swab, HT1319; Swab Applicator, Round Swab, HT1318
DT3542, Dragontail, Microfiber Endoscopic Channel Brush
DT2022, Dragontail, Microfiber Endoscopic Channel Brush; DT2832, Dragontail, Microfiber Endoscopic Channel Brush;
Sterile CleanWIPE® Small Tip Foam Swab, MP1301AST
Sterile CleanWIPE® Medium Tip Foam Swab, MP1302ET-12; MP1302ET-20; MP1302ET-2000; MP1302SE2
Sterile CleanWIPE® Medium Flexible Tip Foam Swab, MP1303ST; MP1303ET; MP1314SE; MP1309ST
SOFTouchTM, General and Oropharyngeal Swab, Regular Foam Tip, Rigid Shaft, Specimen Collection Swab, MP1202ST-HAR
Sterile CleanFOAM Diagnotic, MP1304ST; MP1306ST
SOFTouchTM, Nasopharyngeal Swab, Mini Foam Tip, Flexible Shaft, Specimen Collection Swab, MP1201ST-HAR
Sterile CleanWIPE® Medium Tip Foam Swab, MP1302ST; MP1302ST-12; MP1302ST-20; MP1302ST-2000; MP1308ST
MammoPad® Breast Cushion, MP301; MammoPad® Breast Cushion,MP201; MammoPad® Breast Cushion, MP101
Non-Sterile Swab, 100 PPI, 4.75", HT1138B; SwiperTM Non-Sterile Wiper, MP5001T; MP5002T
Swicker Z100SORB Non-Sterile, MP5209-SY; MP5301-SY; MP5302-SY; MP5303-SY; MP5304-SY; MP5305-SY; MP5306-SY
Swicker Z100SORB Non-Sterile, MP5307-SY; MP5308-SY; MP5309-SY; MP5401-SY; MP5402-SY; MP5403-SY; MP5404-SY
Swicker Z100SORB Non-Sterile, MP5405-SY; MP5406-SY; MP5407-SY; MP5408-SY; MP5409-SY
Swicker Z100SORB Non-Sterile, MP5201-SY; MP5202-SY; MP5203-SY; MP5204-SY; MP5206-SY; MP5207-SY; MP5208-SY
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device