FDA Registration
Active
🇹🇭 Thailand
Nipro (Thailand) Corporation Limited
Reg #: 8041145
·
FEI: 3002974635
·
Expires 2026
Products
9
Proprietary Names
10
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- Nipro (Thailand) Corporation Limited
- Registration Number
- 8041145
- FEI Number
- 3002974635
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 10/2 Moo 8, Bangnomko,
- City
- SENA Phra Nakhon Si Ayutthaya
- Country
- TH
Regulatory Submissions
- 510(k) Number
- K944355
Owner / Operator
- Firm Name
- NIPRO CORPORATION
- Operator Number
- 8030375
- Address
- 3-26, Senriokashinmachi
- City
- Settsu
- State
- Osaka
- Postal Code
- 566-8510
- Country
- JP
- Correspondent
- Nobuhiro Morimoto
US Agent
- Business Name
- NIPRO MEDICAL CORPORATION
- Contact Name
- JESSICA OSWALD-MCLEOD
- Address
- 3150 NW 107th Ave
- City
- Doral
- State
- FL
- ZIP
- 33172
- Country
- US
- [email protected]
- Phone
- 305 4326699
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2006-11-06 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2006-11-06 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2017-03-21 |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | Class 2 | Gastroenterology, Urology | No | 2012-11-22 |
| Protector, Transducer, Dialysis | FIB | Class 2 | Gastroenterology, Urology | No | 2008-03-31 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2008-02-19 |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | Class 2 | Gastroenterology, Urology | No | 2019-09-08 |
| Needle, Fistula | FIE | Class 2 | Gastroenterology, Urology | No | 2010-04-13 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2026-06-11 |
Proprietary Names
Syringe, Piston
NIPRO SAFETOUCH IV CATHETER winged
NIPRO SAFETOUCH IV CATHETER
Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protector and Priming Set
NIPRO Transducer Protector TP-SURE
Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle
Surdial DX Hemodialysis System and Accessories
NIPRO BioHole Needle with CAPICK
Scab Remover
BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Hold
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)