Data / Medical devices / Vietnam / M.E.Nikkiso Vietnam Co., Ltd.
M.E.Nikkiso Vietnam Co., Ltd.: FDA-registered device maker in Quang Ngai, Vietnam, 2 510(k) clearances
M.E.Nikkiso Vietnam Co., Ltd. is registered with the FDA (registration 3027859369) in Quang Ngai, Vietnam. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated May 15, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3027859369
- Address
- No.8, Road No.7, Viet Nam Singapore Industrial Park, Tho Phong Commune, Quang Ngai, Vietnam, 570000
- Owner or operator
- NIKKISO CO., LTD. (8031561)
- Roles
- Manufacturer
- First device listed
- August 15, 2023
- Registered through
- 2027
- Brand names listed
- AL-CDC-E(U) BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop), AV06C-E Blood Tubing Lines for Hemodialysis, C18SFD-E(U) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Blood Circuit, Hemodialysis | KOC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 15, 2025 | K242176 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U) | KOC | Substantially Equivalent | NIKKISO CO., LTD. | accessdata.fda.gov |
| July 28, 2023 | K231589 | Blood Tubing Lines for Hemodialysis AV06C-E | KOC | Substantially Equivalent | NIKKISO CO., LTD. | accessdata.fda.gov |
Compare with other makers
Updated May 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.