FDA Registration
Active
🇹🇭 Thailand
KAWASUMI LABORATORIES (THAILAND) CO., LTD.
Reg #: 9615908
·
FEI: 3003282181
·
Expires 2026
Products
10
Proprietary Names
2
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- KAWASUMI LABORATORIES (THAILAND) CO., LTD.
- Registration Number
- 9615908
- FEI Number
- 3003282181
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 48 MU 8, RATCHASIMA-CHOK CHAI RD,, TAMBON THA ANG, AMPHOE
- City
- CHOK CHAI Nakhon Ratchasima
- Country
- TH
Regulatory Submissions
- 510(k) Number
- K001424
Owner / Operator
- Firm Name
- SB-KAWASUMI LABORATORIES, INC.
- Operator Number
- 8031539
- Address
- 3-25-4 Tonomachi, Kawasaki-ku
- City
- Kawasaki-shi
- State
- Kanagawa
- Postal Code
- 210-8602
- Country
- JP
- Correspondent
- Kenichi - Inamura
US Agent
- Business Name
- MIC International
- Contact Name
- Deno Zachary
- Address
- 201 East 69th Street, Suite 5O,
- City
- New York
- State
- NY
- ZIP
- 10021
- Country
- US
- [email protected]
- Phone
- 917 3315789
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2008-03-03 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2023-03-14 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2023-06-09 |
| Needle, Fistula | FIE | Class 2 | Gastroenterology, Urology | No | 2010-04-21 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2018-10-11 |
| Set, Transfer (Blood/Plasma) | KSB | Class 2 | Hematology | No | 2018-10-11 |
| Apparatus, Autotransfusion | CAC | Class 2 | Anesthesiology | No | 2015-09-17 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2008-03-03 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2008-01-09 |
| Non-Coring (Huber) Needle | PTI | Class 2 | General Hospital | No | 2026-04-20 |
Proprietary Names
Haemonetics Cell Saver System
Haemonetics Cell Saver Elite System
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)