FDA Registration
Active
🇹🇭 Thailand
INFUS MEDICAL (THAILAND) CO., LTD.
Reg #: 9680340
·
FEI: 1000434163
·
Expires 2026
Products
10
Proprietary Names
9
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- INFUS MEDICAL (THAILAND) CO., LTD.
- Registration Number
- 9680340
- FEI Number
- 1000434163
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 706 MOO 4, Bangpoo Industrial Estate, I-EA-T Free Zone, Tambon Preaksa
- City
- Amphoe Muang Samutprakarn Samut Prakan
- Country
- TH
Owner / Operator
- Firm Name
- Infus Medical (Thailand) Co., Ltd.
- Operator Number
- 9008323
- Address
- 706 Moo 4, Bangpoo Industrial Estate,, I-EA-T Free Zone, T. Preaksa, A. Muang
- City
- Samutprakarn
- State
- TH-NOTA
- Postal Code
- 10280
- Country
- TH
- Correspondent
- Patcharin - Vinitwatanakhun
US Agent
- Business Name
- Pragmatic Compliance dba FDAbasics
- Contact Name
- Jerry Doane
- Address
- 15815 SW 11th Court Rd
- City
- Ocala
- State
- FL
- ZIP
- 34473
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2023-08-25 |
| Insufflator, Hysteroscopic | HIG | Class 2 | Obstetrics/Gynecology | No | 2014-01-30 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2025-06-04 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2007-11-13 |
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2011-08-12 |
| Insufflator, Endoscopic Vessel Harvesting | OSV | Class 2 | Obstetrics/Gynecology | No | 2020-08-13 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2011-08-12 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2013-06-07 |
| System, Peritoneal, Automatic Delivery | FKX | Class 2 | Gastroenterology, Urology | No | 2022-08-29 |
| Bag, Urine Collection, Newborn | FOC | Class 2 | Gastroenterology, Urology | No | 2024-09-20 |
Proprietary Names
SenoRx Inc.
EnCor MRI Introducer Set
TITANIUM HEMOSTATIC CLIP
Insufflation Tubing Set, HE+SE+HU
CloudCath Peritoneal Dialysis Drain Set Monitoring System
EnCor Breast Biopsy Probe with Rinse Tube
Breast Tissue Marker
SenoRx
Tubeset for Arthroscopy Pump
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)