FDA Registration
Active
🇻🇳 Vietnam
M.E.Nikkiso Vietnam Co., Ltd.
Reg #: 3027859369
·
FEI: 3027859369
·
Expires 2026
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
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Registration Details
- Registration Name
- M.E.Nikkiso Vietnam Co., Ltd.
- Registration Number
- 3027859369
- FEI Number
- 3027859369
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.8, Road No.7, Viet Nam Singapore Industrial Park, Tho Phong Commune
- City
- Quang Ngai
- Country
- VN
Regulatory Submissions
- 510(k) Number
- K242176
Owner / Operator
- Firm Name
- NIKKISO CO., LTD.
- Operator Number
- 8031561
- Address
- 20-3 EBISU 4-CHOME,
- City
- SHIBUYA-KU
- State
- Tokyo
- Postal Code
- 150-6022
- Country
- JP
- Correspondent
- Satoko Hina
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 |
|---|---|---|---|---|---|
| Accessories, Blood Circuit, Hemodialysis | KOC | Class 2 | Gastroenterology, Urology | No | 2025-08-01 |
Proprietary Names
AL-CDC-E(U) BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop)
C18SFD-E(U) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series
AV06C-E Blood Tubing Lines for Hemodialysis
Establishment Types
Manufacture Medical Device